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| Model Number 6971650 |
| Device Problem
Break (1069)
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| Patient Problem
Pain (1994)
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| Event Date 12/08/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Revision surgery scheduled for (b)(6) 2022.G4: part#6971650 is not approved for use in the united states; however a like device catalog# 6972650, pma# p090029/s003 and udi # (b)(4) was cleared in the united states.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a distributor, healthcare professional via a manufacturer representative regarding a patient implanted with disc.Pre-operative diagnosis was chronic pain at the cervical-uls regions associated with dd/odc c3-7; c3-4 lt foraminal l stenosis; c4-5-6-7 bilateral foraminal stenosis.Procedure performed was anterior cervical microdiscectomy-decompression c3-7; c3-4 and c6-7 arthroplasty (cda) + c4-5-6 fixation for fusion (acdf).Levels implanted was c3-4 and c6-7 arthroplasty.It was reported that post-operatively, presenting broken superior past of the artificial disc c6-7.Patient complained of worsening of his ul (upper limbs) pain after surgery.It was reported that patient had initial good result after surgery (b)(6) 2021, however, patient started complaining of worsening of his pain at his upper limbs (uls) since the last 1-2 months (around (b)(6) 2021)).Patient is willing to have revision surgery on early (b)(6) 2022, to remove the broken artificial disc c6-7 and perform a traditional fusion (acdf c6-7), using tricortical bone allograft + anterior cervical plate for fixation and fusion.Patient had conservative treatment for pain, including pain control with analgesics, trigger point injection (or similar) and physiotherapy, with partial relive of his pain.
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Manufacturer Narrative
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Revision surgery scheduled for (b)(6) 2022.Part#6971650 is not approved for use in the united states; however a like device catalog# 6972650, pma# p090029/s003 and udi # (b)(4) was cleared in the united states.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a distributor, healthcare professional via a manufacturer representative regarding a patient implanted with disc.Pre-operative diagnosis was chronic pain at the cervical-uls regions associated with dd/odc c3-7; c3-4 lt foraminal l stenosis; c4-5-6-7 bilateral foraminal stenosis.Procedure performed was anterior cervical microdiscectomy-decompression c3-7; c3-4 and c6-7 arthroplasty (cda) + c4-5-6 fixation for fusion (acdf).Levels implanted was c3-4 and c6-7 arthroplasty.It was reported that post-operatively, presenting broken superior past of the artificial disc c6-7.Patient complained of worsening of his ul (upper limbs) pain after surgery.It was reported that patient had initial good result after surgery (b)(6) 2021, however, patient started complaining of worsening of his pain at his upper limbs (uls) since the last 1-2 months (around (b)(6) 2021)).Patient is willing to have revision surgery on early (b)(6) 2022, to remove the broken artificial disc c6-7 and perform a traditional fusion (acdf c6-7), using tricortical bone allograft + anterior cervical plate for fixation and fusion.Patient had conservative treatment for pain, including pain control with analgesics, trigger point injection (or similar) and physiotherapy, with partial relive of his pain.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from manufacturer representative reported that the revision surgery had been performed on (b)(6) 2022.Broken prestige disc was removed and replaced it with divergence cage and the patient doing fine after his redo case.
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Manufacturer Narrative
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B5 additional information continued: (b)(6) 2021: patient complained of severe generalized pain, 7/10, anxious.Assessed, ordered 2mg iv morph along with giving oxy ir 5 mg q4 hours sharply.Anesthiology doctor visited the patient and provided the treatment.Discharge notes: patient is now comfortable, pain well controlled, no new complaints, vitals stable, tolerating oral feeds and mobilizing well independently.Patient was reviewed by the consultant, happy with progress, can be discharged home with outpatient follow up.(b)(6) 2021: patient underwent xr spine cervical 2 or 3 views post op.X-ray cervical spine ap and lateral views with flexion and extension.Findings: decreased cervical lordosis.Surgical intervention, anterior fixation of c4, c5 and c6.Disc spacer is seen between c3-c4 down to c6-c7 levels.No criteria of spinal instability.Cervical spondylosis with osteophytosis.Narrowed c7-t1 disc space.No bony cervical rib.No abnormal paraspinal calcifications.(b)(6) 2021: patient visited the hospital for follow-up after early postoperative anterior cervical microdiscectomy with decompression and arthroplasty c3-c4 and c6-c7 and fusion c4-c5 and c5-c6.Physical examination by the doctor confirmed that the wound is healing well.Investigational results: the initial x-ray shows that all the implants are in good position.Assessment/plan: doctor assessed that the patient is recommended to follow the postoperative protocol after cervical hybrid surgery, take medication as prescribed, and come for the first dressing next week with patient¿s companion.(b)(6) 2021: patient visited the hospital for follow-up after early postoperative anterior cervical microdiscectomy with decompression and arthroplasty c3-c4 and c6-c7 and fusion c4-c5 and c5-c6.Patient is having very good recovery.The neck and arm pain are getting better, but patient feels some weakness and discomfort in his left shoulder, which can be attributed for the position during the surgery where surgeon put the tapes to pull both arms.Doctor suggested patient to see shoulder specialist and start physiotherapy as soon as possible.Physical examination by the doctor confirmed that the wound is healing very well, and it is completely dry and healed.Assessment/plan: doctor assessed the patient¿s condition and prescribed medication for pain and physiotherapy.Doctor suggested that patient should have another x-ray and assessment in around 1 month after the surgery or as needed.(b)(6) 2021: patient visited the hospital for follow-up after early postoperative anterior cervical microdiscectomy with decompression and arthroplasty c3-c4 and c6-c7 and fusion c4-c5 and c5-c6.Patient is having good recovery, but still has some pain, stiffness and discomfort in his neck, upper back and shoulders.Patient still feels a bit weak in his left upper limb which can be associated with traction on his shoulders during the surgery to expose his neck for the lateral view of the x-ray, where the surgeon put both arms down as part of the procedure for better lateral exposure, also previous shoulder problem, chronic radiculopathy and upper limbs injury.Patient having good recovery and visited the hospital to get more medication for pain.Patient doesn¿t have cervicobrachial pain anymore but visited the hospital with severe pain at his left parascapular region, which is typical of muscular spasm or trigger points.Physical examination by the doctor confirmed that there are no neurological findings.Investigation results: the previous x-ray looks fine.Assessment/plan: doctor assessed and suggested the patient to take medication for pain, physiotherapy, and have a left parascapular trigger point injection asap to help to alleviate the localized pain.(b)(6) 2021: patient visited the hospital for follow-up after postoperative anterior cervical microdiscectomy with decompression and arthroplasty c3-c4 and c6-c7 and fusion c4-c5 and c5-c6.Patient is making good progress following cervical multilevel disc stabilization and disc replacement surgery.Left shoulder symptoms per se are settling down.Weakness in the left arm going into the thumb is overall making improvements with physiotherapy and the patient is very pleased with his progress.Doctor understood that patient was evaluated for left shoulder postop pain and an mri performed at another facility had showed cuff impingement with the interstitial tear of the supraspinatus.Clinical findings: left shoulder has periscapular muscle wasting which is chronic and related to the persisting ongoing cervical neuropathy changes.Old distal biceps tendon tear noted and has pop i side.Weakness in thumb abduction noted.Negative hawkins kennedy's tests and therefore negative for cuff impingement at this stage.Overall supraspinatus and rest of the cuff muscles are functioning however chronic weakness is noted.Reviewed mri report as a scan was not available which confirms interstitial small tear within the supraspinatus with features of impingement syndrome.X-rays of patient¿s cervical spine shows stable fusion surgery and disc replacements in the good position.Assessment/plan: doctor assessed the patient¿s condition and recommended the patient to continue with regular physiotherapy for his cervical spine and left shoulder for strengthening program.(b)(6) 2021: patient underwent xr spine cervical 2 or 3 views post-op.X-ray cervical spine ap and lateral views with flexion and extension.Findings: decreased cervical lordosis.Surgical intervention, anterior fixation of c4, c5 and c6.Disc spacer is seen between c3-c4 down to c6-c7 levels.No criteria of spinal instability.Narrowed c7-d1 disc space.No bony cervical rib.No abnormal paraspinal calcifications.17 august 2021: patient visited the hospital for follow-up after almost 2 months¿ postoperative anterior cervical microdiscectomy with decompression and hybrid cervical surgery c3-c4 and c6-c7 arthroplasty plus c4-c5 and c5-c6 fixation for fusion.Patient is initially having weakness in his left upper limb, but he also has previous history of biceps injury and surgery many years ago done in another hospital which also contributes to the weakness in his left upper limb after surgery.Now, patient¿s recovery is going very well.He has minimum pain, and the strength is improving significantly with physiotherapy.Investigation results: the new x-ray; there is no report yet, shows that the artificial disc, bone graft and plate are in good position.It also shows good healing process.Assessment/plan: doctor assessed and advised the patient to continue medication for pain as needed, physiotherapy, pain clinic or acupuncture as needed, and following the postoperative protocol for hybrid cervical surgery.(b)(6) 2021: patient visited the hospital for follow-up.Patient had a good recovery regarding his neck, but he still has some pain, comes and goes to his right upper limb especially on both shoulders.Patient also has weakness in his both upper limbs.The previous injury of his deltoid muscles, besides other sport injuries, is also contributing to his symptoms, he also has some problem in his shoulder which is being treated by dr shine.Patient states that his pain is fine and is gradually getting better, but now it is bothering him again especially the pain in his arms, worst on the right side.Investigation results: some investigations were done after the surgery, but no abnormalities observed.Assessment/plan: doctor assessed the patient¿s condition and wanted to be sure that no compression coming from patient¿s cervical spine because some investigations after the surgery did not see any abnormalities and as his pain in the arms is bothering him and getting worse since the last few days, it is very important to rule out any compression on the nerves in his cervical region.So, doctor requested for a cervical mri.Patient can continue medication for pain, physiotherapy, pain clinic or acupuncture, and treatment with dr shine regarding his shoulder.(b)(6) 2021: patient underwent mri spine cervical w/o contrast.Findings: postoperative status: evidence of previous anterior cervical discectomy and fusion (acdf) at c4-5 and c5-6 levels with anterior plate and screws and intervertebral disc space cages.C3-4 and c6-7-disc replacement materials are also noted.Suboptimal evaluation due to ferromagnetic artifacts of metallic surgical materials.Straightened cervical curvature.Normal sagittal diameter of the bony cervical spinal canal.Normal marrow signal of scanned vertebral bodies and neural arches.C6-7 posterior disc protrusion is seen obliterating the anterior subarachnoid space, indenting the cervical cord and encroaching upon both exiting neural foramina.Normal mr appearance of the cervical cord, cranio-cervical, cervico-dorsal and cervico-medullary junctions.Hypertrophic osteoarthritic changes of the bilateral neurocentral joints from c3-4 down to c6-7 levels.Bilateral facet arthropathy of c5-6 and c6-7.No abnormal paraspinal soft tissues.Opinion: postoperative status, acdf of c4-5, c5-6 with disc cages and c3-4 and c6-7-disc replacement.Suboptimal evaluation due to ferromagnetic artifacts of metallic surgical materials.C6-7posterior disc protrusion.Hypertrophic osteoarthritic changes of the bilateral neurocentral joints from c3-4 down to c6-7 levels.Bilateral facet arthropathy of c5-6 and c6-7.(b)(6) 2021: patient visited the hospital for follow-up after almost two months and a half postoperative anterior cervical mic rodiscectomy with decompression and fusion c4-c5 and c5-c6 and artificial disc c3-c4 and c6-c7.Patient at almost two months and a half with good result.Patient¿s cervicobrachial pain has decreased quite a lot, but he is still complaining of some pain especially in his right shoulder and right scapular region, with gradual recovery.Physical examination by the doctor showed no relevant abnormalities.Investigation results: the x-ray and mri did not show any relevant abnormality, only the signs of the implants in proper position.There is no sign of infection, bleeding, hematoma, or abscess, which is the main goal to rule out any of those complications.The x-ray also completed; there is no report yet, but it looks that all the implants are fine and in good position.Assessment/plan: patient is still taking brufen from his side despite the fact that doctor told him not to take anti-inflammatory and not to smoke cigarettes after the surgery, which is also written on the postoperative protocol after cervical hybrid surgery.So, doctor highlighted to patient that he should avoid anti-inflammatory, except for short period, as needed, and do not smoke for three to six months after the surgery to increase the chance of a good bone fusion.Patient understoodthat and he stated that he will avoid taking the "brufen", unless if really required.For this reason, doctor prescribed the patient "lagaflex and zaldiar" as needed for pain and to relax his muscles, and "zolpidem" because patient has insomnia.Doctor would like to continue his follow-up with another x-ray and assessment at six months after surgery, or as needed.Doctor recommended medication for pain and physiotherapy only as needed.(b)(6) 2021: patient underwent x-ray cervical spine ap and lateral views with flexion and extension.Findings: evidence of previous anterior cervical discectomy and fusion (acdf) at c4-5 and c5-6 levels with anterior plate and screws and intervertebral disc space cages.C3-4 and c6-7-disc replacement materials are also noted.Decreased cervical lordosis.No sign of spinal instability on flexion-extension views.Narrowed c7-d1 disc space.No bony cervical rib.No abnormal paraspinal calcifications.(b)(6) 2021: patient underwent xr spine cervical complete.X-ray cervical spine ap and lateral views with flexion and extension.Findings: evidence of previous surgical intervention.Acdf at c4-5 and c5-6 levels with anterior plate and screws.Artificial disc is seen at c3-c4 and 67 level.No evidence of hardware failure.Straightening of the cervical lordosis.Minimal anterior displacement of c2 over c3.Spondylotic changes of the cervical spine.Narrowed c7-d1 disc space.No bony cervical rib.No abnormal paraspinal calcifications.(b)(6) 2021: patient underwent ct spine cervical w/o contrast.Findings: post operative status anterior cervical microdiscectomy decompression c3-c7 with fusion.The surgical hardware appears in place with normal bone density around, no criteria of loosening.No subsidence.Obliteration of the normal cervical lordosis.Spondylotic changes of the cervical spine with sharpening, sclerosis and irregularity of the endplates together with marginal osteophytosis.At the level of c6-c7, there is marginal osteophytosis encroaching upon the neural foramina more on the right side compromising right c7 nerve root.There is marginal osteophytosis seen at c3-c4, c4-c5 and c5-c6 levels encroaching upon the foramina more on the left.Arthropathic changes of the facet joints are seen.The posterior vertebral arches appear intact.Average anteroposterior dimension of the bony spinal canal.Intact craniocervical junction.Opinion: status post microdiscectomy decompression c3-c4, intact hardware with no failure.Cervical spondylosis with marginal osteophytosis.Marginal osteophytes encroaching upon the neural foramina more on the right side at c6-c7 level.C3-c4, c4-c5 and c5-c6 marginal osteophytosis attenuating the neural foramina.19 december 2021: patient visited the hospital for follow-up postoperative anterior cervical microdiscectomy with decompression and multiple levels of cervical disc replacement c3-c4, c4-c5, c5-c6 and c6-c7.Doctor spoke with patient via whatsapp and requested him to see an ent doctor for a preoperative checkup of his vocal cord which is a kind of protocol when there is any additional surgery in the anterior cervical region; it is always advised to have an ent assessment to check the status of the vocal cord because we are planning to go on the opposite side to avoid the deep scar tissue.Doctor is planning to do another cervical surgery on patient¿s neck.Patient had done anterior cervical approach for multiple levels of cervical disc disease using the anterior left side to expose from c3 to c7 to perform microdiscectomy with decompression and fixation with artificial disc c3-c4 and c6-c7 and fusion c4-c5 and c5-c6.The first surgery went smoothly; however, according to the latest regular follow-up, it was noted that the artificial disc at c6-c7 is broken.Patient is fine and neurologically not compromised.The spinal cord is free.There are no signs of gross instability.Doctor is planning toremove the artificial disc and perform a fusion to extend the previous fusion to this level.Assessment/plan: doctor informed patient and the patient booked the consultation with dr michael, ent, for the assessment.In this case, as a routine, doctor is planning to open from the anterior right side to avoid the deep scar tissues of the left previous approach.For this reason, doctor wants the patient to be assessed by the ent doctor to check his vocal cords from the left side approach is fine.If the vocal cord is fine, then it is safe to go for the right side.If there is any problem in the vocal cords or asymptomatic paresis of the vocal cord, then doctor would have to go from the same side even if it has more risk for the scar tissues.(b)(6) 2021: patient visited the hospital for pre-anesthesia evaluation.(b)(6) 2021: patient visited the hospital for ent evaluation.Physical examination by the ent doctor confirmed that the 45-degree scope gave perfect view of a perfect larynx with normal vocal cord movement.(b)(6) 2022: patient admitted for c6-c7 disc revision with cage due to broken titanium artificial c6-c7 disc with numbness in his both hands especially at night.Surgery performed: anterior cervical approach for removal of broken artificial disc and replacement by stand-alone cage with bone graft c6-7.Surgery description/technique/procedure: patient on supine position, checked the level by fluoroscopy, full protection (anti-dvt, ionm, body and face), prep and drape w antiseptic-sterile technique anterior rt (right) lateral incision w loupe (zeiss 4 x 500 mm), smith robinson surgical approach, exposure c6-7 confirmed by x-ray removal of the broken artificial disc (prestige lt), showing that the superior part was fractured, which was well fixed to the end-plated, but managed to remove in 3 pieces (2 of the superior which was broken and 1 inferior part which was intact), without any problem nor any damage to the vertebral bodies c6-7.Disc space was checked which was clear, no remaining disc nor osteophytes were visualized.The stand-alone cage (17 x 14 x 6 mm; 6 degrees was inserted; divergence; screws 13 x 3.5 mm c6 + 15 x 3.5 mm c7) + 1-2 ml of bone allograft (dbm) in the space c6-7, with good positioning, checked by fluoroscopy = fine; ionm (intraoperative neuromonitoring) was fine during the entire procedure.Revision of the hemostasis (bipolar), washing with saline, closure by layers, dermabond, drain and dressing.Placement of devices/drainages: stand-alone cage (17 x 14 x 6 mm; 6 degrees; divergence; screws 13 x 3.5 mm c6 + 15 x 3.5 mm c7) + 1-2 ml of bone allograft (dbm) in the space c6-7 (medtronic) doctor.Checked the area, and it is completely clean.No disc protrusion.No bone osteophytes and nothing compressing the spinal cord or nerve roots.Doctor replaced the artificial disc using a fusion technique with a standalone cage, divergence, with bone allograft inside the cage with two screws (one to fix at c6 and another to fix at c7 vertebral body) with a very good insertion of the implant.Doctor checked during whole procedure with intraoperative neuromonitoring under fluoroscopy.Everything was fine.Physical exam: the patient is having initial good recovery.Patient is moving his forelimbs.No neurological deficits.Patient stated that his arm pain is getting better which he was complaining previously.Patient stated that the surgery is not so painful at this time.There is no bleeding, no swelling in his neck.Patient has a very good respiratory pattern.All the vital signs are stable.Complications: none.Doctor assessed and advised that the patient would continue with observation by hdu, myself and our team plus the hospitalist.Patient should follow the postoperative protocol after cervical fusion and cervical collar for sitting and walking.(b)(6) 2022: discharge summary: patient with more of a numbness in his both hands especially at night broken titanium artificial c6-c7 disc.Patient at six months¿ postoperative anterior cervical microdiscectomy with decompression and arthroplasty at c3-c4 and c6-c7 and fusion at the level of c4-c5 and c5-c6 using tricortical bone allograft with anterior cervical plate.Patient at six months postoperative for treatment of multiple levels of cervical disc disease when we performed an anterior cervical microdiscectomy with decompression and arthroplasty at c3-c4 and c6-c7 where there is more soft disc herniation and we also performed fusion at the level of c4-c5 and c5-c6 using tricortical bone allograft with anterior cervical plate.Patient is doing quite well and his cervicobrachial pain is improving gradually.In the last few weeks, patient complained more of a numbness in his both hands especially at night.Patient had history of carpal tunnel syndrome which was mild.No cervical pain at this moment.No pain to the upper limbs.The cervical is now grade 1 because there is some discomfort like muscular pain as he described it.In his upper limbs, there is no pain at this moment, but there is grade 1 or 2 mild discomforts in his right hand and grade 1 on the left hand.Review of systems: patient was assessed by another specialist because patient also has shoulder pain and previous left biceps rupture, for which he had surgery when he was in us long time ago.Patient also has problems in his left wrist where he had the surgery previously done outside.Phy sical examination by the doctor showed that patient has mild cervicobrachial discomfort with flexion.No neurological findings except he has mild hypertrophy on his left hand close to the thumb area which can be attributed to his previous chronic cervicobrachial pain associated with multiple levels of cervical disc disease and also left biceps and wrist surgeries done outside related to previous injuries.Investigation results: the newest x-ray shows that the artificial disc at c3-c4 looks in very good position and c4-c5 and c5-c6 fusion are also doing very well.At the level of c6-c7, doctor noted patient has failure of the lowest prosthesis of the artificial disc at c6-c7.The superior endplate of the disc collapsed and is not working very well.It looks like the superior endplate of the artificial disc prestige lp is broken because of the subsidence of the bone and the fusion just above the disc space.All the other levels look fine.Assessment/plan: doctor assessed that the broken titanium artificial c6-c7 disc for revision with cage.H ospital course: the patient was brought in as a planned admission for above mentioned diagnosis and he underwent an elective surgery, with an uneventful intra op and post op period.The patient is now comfortable, pain well controlled, no new complaints, vitals stable, tolerating oral feeds and mobilizing well independently.He has been reviewed by the consultant, happy with progress, can be discharged home with outpatient follow up.Significant findings: postoperative for multilevel cervical disc disease with failure of arthroplasty c6-7 due to broken artificial disc.Procedures and treatment provided: anterior cervical approach for removal of broken artificial disc and replacement by stand-alone cage with bone graft c6-7.Patient is at postoperative anterior cervical revision for removal of artificial disc c6-c7 for implantation of stand-alone cage with bone graft for fusion.Physical examination by the doctor confirmed that the patient is having a very good recovery, minimum pain and no neurological deficits.The wound is in good status; there is only minimum amount of blood in the gauze which is connected to the penrose drain.No respiratory or any other issue.Patient is going to be discharged to the ward.Investigation results: the x-ray looks fine.Assessment/plan: doctor assessed the patient¿s condition and advised the patient that he should follow the postoperative guidelines after cervical fusion, wearing the cervical collar for sitting or walking for about 6 to 12 weeks according to the follow-ups.(b)(6) 2022: patient underwent xr spine cervical 1 view portable post-op.Findings: status post anterior cervical microdiscectomy with decompression and arthroplasty at c3-c4 and c6-c7 and fusion at the level of c4-c5 and c5-c6 using tricortical bone allograft with anterior cervical plate showing good alignment.Normal osseous texture and trabecular pattern of the examined vertebral bodies and neural arches.Straightened cervical curvature.No bony cervical ribs.(b)(6) 2022: patient visited the hospital for follow-up after early postoperative anterior cervical fusion c6-c7 with stand-alone cage and bone allograft.Patient is at early postoperative anterior cervical fusion c6-c7 with stand-alone cage and bone allograft, with a very good result.Patient¿s pain has improved in his upper limbs.Assessment/plan: the patient came for the first dressing today and his healing is going very well.The wound care nurse team also came to assist the doctor and to do the first dressing with doctor.The wound care nurse stated that the healing is doing great so patient can continue doing it at home or can do it here at the hospital, which ever patient prefers.Patient and his wife were taught how to do the dressing and they can do it at home for one more week, every other day.Doctor gave medication for pain and for insomnia to take as needed.(b)(6) 2022: patient visited the hospital for follow-up after postoperative anterior cervical fusion c6-c7 with stand-alone cage and bone allograft.Patient contacted the doctor informing that he woke up with some tingling in his hands.Doctor immediately suggested the patient to visit the hospital to do a clinical and image assessment.Physical examination by the doctor confirmed that neurologically patient is fine and there are no neurological deficits.Investigation results: patient did an x-ray right now; there is no report yet, but all the prosthesis in the cervical spine is in good position.There are no signs of any dislocation or any problem with the implants and it looks like the bone fusion is going well.Assessment/plan: doctor assessed and informed the patient that he shall continue the same protocol and the follow up as per the recommendation in the past.Patient can start physiotherapy for more comfort and more advice about the posture and so on.(b)(6) 2022: patient underwent xr spine cervical 2 or 3 views post-op.Plain x-ray of cervical spine ap and lateral views.Findings: post-surgical changes are noted with anterior fusion is seen at c4 throughout c6 with postsurgical changes involving the discs of c3-c4 and c6-c7, and anterior fusion at c6-c7, the hardware is noted in situ.Spondylosis changes are noted.No bony cervical ribs.Decreased bone density.(b)(6) 2022: patient underwent xr spine cervical complete for anterior cervical approach for removal of broken artificial disc and replacement by stand-alone cage with bone graft c6-7.X-ray cervical spine ap and lateral views with flexion and extension.Findings: postoperative status: evidence of previous anterior cervical discectomy and fusion (acdf) at c4-5, c5-6 and c6-7 levels with anterior plate and screws and intervertebral disc space bone allograft.C3-4-disc replacement materials are also noted.No sign of hardware failure.Decreased cervical lordosis.No sign of spinal instability on flexion-extension views.No bony cervical rib.No abnormal paraspinal calcifications.Physiotherapy performed on the patient on below dates: (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, (b)(6) 2021, 08 (b)(6) 2021, (b)(6) , (b)(6) 2021, (b)(6) 2021, (b)(6) 2022, (b)(6) 2022.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from manufacturer representative reported that the ct scan clearly showed that the upper half of the artificial disc implanted between the c6/7 was completely broken into two pieces across the ¿ball¿ section of the ¿ball-in-trough¿.Surgery to remove the broken disc was performed on (b)(6) 2022.The faulty disc was removed by the surgical team, and the c6/7 vertebrae were unfortunately fused as the cervical joint was no longer a good candidate for an artificial disc.Inspection of the broken disc showed that it broke clearly around the ¿ball¿ section of the ¿ball-in-trough¿ disc.No apparent bending of either piece seems evident.The lower half of the disc has scratches on its surface where the broken piece of the upper portion had been rubbing across it during movement of the joint after it had broken.Below mentioned information received on 2022-feb-23: implant date(s): (b)(6) 2022 patient demographics: gender- male; initials- d.R; dob/age- (b)(6) 1969; dob/age- 52 years; race- white; height-177; weight- 88kg; ethnicity: non-hispanic or latino.History/comorbidities: (pre-existing medical conditions, smoking status, prior surgeries) herniation of cervical intervertebral disc with radiculopathy, neuralgia, cervical degenerative disc disease, insomnia, neuritis, hx of arthroplasty, hypertension, carpal tunnel syndrome on both sides.Surgeries: inguinal hernias surgery 4 times, left wrist arthroscopy, right shoulder surgery, multiple sports injuries or similar, left biceps traumatic rupture.Allergies/intolerance: morphine.Family medical: no family history items have been available.Social history: never smoker.Medication: lidocaine 5% patch (versatis, 30s), t coveran 10/10, t nataralax.15mg, zolpidem 5 mg oral tablet, acetaminophen/caffein e/codeine 500 mg-30 mg-8 mg oral tablet (solpadeine), celecoxib (algoxib, 30's) 200mg caps, diclofenac sodium 140 mg medicated plaster patches, esomeprazole 20 mg cap (nexium, 14's), ondansetron 4 mg tab, oxycodone 10 mg oral tablet, oxycodone 5 mg oral tablet, ox ycodone-acetaminophen 10 mg-325 mg oral tablet, paracetamol-carisoprodol 250mg-300mg oral tablet, pregabalin 75 mg cap, (14's), tramadol-paracetamol 37.5mg-325mg oral tablet, parecoxib 40mg powder for injection, methylprednisolone (as sodium succinate) 500mg/8ml powder for injection (solu medrol), cefazolin 1g powder for injection.It was reported that on: (b)(6) 2021: patient visited the hospital for consultation with chronic cervical pain.The patient is a 51-year-old gentleman, an american pilot, came in today with history of chronic cervical pain which started radiating to his both upper limbs and getting worse since the last 8 to 9 months including some numbness, weakness, and heaviness in his both upper limbs and hands.No spinal trauma.Patient cervical pain is grade 3/10 to 4/10, right upper limb is 3/10 to 4/10, left upper limb is 2/10 to 3/10 but sometimes getting much worse especially at night.Review of systems: the patient has hypertension under control.He had done physiotherapy before, but no improvement of his current cervicobrachial pain.Physical exam: on the spinal exam, patient has spurling test positive to his right upper limb indicating cervical radiculopathy.Patient has mild hypertrophy of his left hand probably related to his previous left wrist surgery.Investigational results: patient brought only one image of his previous mri, which was done in other facility, but it is an open mri.No cd is available.It is showing that he has multiple levels of cervical disc disease at around c3-c4 and from c5 to c7.Assessment/plan: the patient¿s cervicobrachial pain is most likely associated with multiple levels of cervical disc disease.Patient also has shoulder problem, for which doctor advised him to see a shoulder specialist.Doctor requested the patient to have cervical x-ray and mri, medication for pain, and physiotherapy.(b)(6) 2021: patient underwent xr spine cervical complete for chronic pain at the cervical-uls region associated with dd/odc c3-4, ddc5-7 shoulder¿s pain.Findings: straightened cervical curvature.Spondylo-degenerative changes are noted in the form of marginal anterior osteophytes at c3-4 through c6-7 opposing vertebral endplates.Associated subchondral sclerosis is also seen at c5-6 and c6-7 levels.Narrowing at c3-4 through c6-7 intervertebral disc spaces as well as the corresponding neurocentral joints.No bony cervical ribs.(b)(6) 2021: patient underwent mri spine cervical w/o contrast) radiculopathy.Findings: mild obliteration of the normal cervical lo rdosis.Average vertebral alignment, no criteria of spinal instability.Mild cervical spondylosis with sharpening of the vertebral endplates and small marginal osteophytosis.The cervical discs show degenerative changes with decreasedsignal intensity on t2 wi, mildly decreased height of c6-c7 disc noted.C4-c5 disc shows left foraminal focal protrusion with small osteophytosis attenuating the left neural foramen and compromising left c5 nerve root.C5-c6 disc shows diffuse bulge associated with marginal osteophytosis, this is attenuating the neural foramina compromising c6 nerve roots.C6-c7 disc shows asymmetrical bulge with small osteophytosis and attenuating the neural foramina compromising c7 nerve roots.Uncovertebral joint arthropathy is seen at different cervical levels.The cervical cord shows average size and signal intensity, no intramedullary focal lesions, no malacia or syrinx.Average anteroposterior dimension of the bony spinal canal.Intact craniocervical junction.No bone marrow infiltrative lesions.No abnormal paraspinal soft tissue masses or localized fluid collection.Opinion: secondary changes of neck muscle spasm.Cervical spondylosis with degenerated cervical disks.C4-c5 left foraminal disc protrusion compromising left c5 nerve root.C5-c6 and c6-c7 disc bulges/osteophytosis attenuating the neural foramina compromising c6 and c7 nerve roots.Uncovertebral joint arthropathy.30 may 2021: patient visited the hospital for consultation.Investigation results: doctor examined the patient¿s x-ray and mri of th e cervical spine, which were done because of his chronic cervicobrachial pain to both upper limbs.It shows that patient has multiple levels of cervical disc disease from c3 to c7 with left-sided severe foraminal stenosis at c3-c4 and severe bilateral foraminal st enosis from c4-c5, c5-c6, and c6-c7.Assessment/plan: doctor assessed that in this case, he is considering surgical treatment.For this reason, doctor requested the patient to get cervical ct scan to better clarify if the surgery will be artificial disc or fusion or combination of both, and also to analyze the anatomical protrusion in the neural foramen which is very important to be seen in the ct scan.Because the mri is better to see the soft tissues and the ct scan is to see the bone osteophytes.Patient was asked to continue medication for pain, physiotherapy, pain clinic or acupuncture.(b)(6) 2021: patient underwent ct spine cervical w/o contrast for chronic pain in neck.Findings: straightened cervical curvature.Normal sagittal diameter of the bony cervical spinal canal.Spondylo-degenerative changes are noted in the form of marginal anterior osteophytes and subchondral sclerosis at c3-4, c5-6 and c6-7 opposing vertebral endplates.Reduced height of all scanned intervertebral disc spaces apart from c2-3 and c4-5 levels.Dense scattered foci are noted at c3-4 and c4-5 level.C4-5 posterior and left posterolateral disc bulge/osteophyte complex is seen obliterating the anterior subarachnoid space and indenting the cervical cord.C5-6 and c6-7 diffuse posterior disc bulge/osteophyte complexes are seen obliterating the anterior subarachnoid space, indenting the cervical cord, and encroaching upon both exit neural foramina more evident on the left side.Hypertrophic osteoarthritic changes of the neurocentral joints from c3-4 down to c6-7 levels with consequent corresponding foraminal stenosis more evident on the left side.No bony cervical ribs.Opinion: c4-5 posterior and left posterolateral disc bulge/osteophyte complex.C5-6 and c6-7 diffuse posterior disc bulge/osteophyte complexes.C3-4 down to c6-7 neuro-central joints hypertrophic osteoarthritic changes more evident on the left side.(b)(6) 2021: patient visited the hospital for consultation.Investigation results: patient brought the cervical ct, mri and x-ray t hat the doctor has recommended all together.Patient has multiple levels of cervical disc disease from c3 to c7 with severe foraminal stenosis at c3-c4 to the left side and c4-c5 and c5-c6 bilateral stenosis with bone protrusion associated with that in multiple levels.Assessment/plan: doctor assessed that the patient has multiple levels of cervical disc disease with severe foraminal stenosis, and some levels have bone stenosis associated with disc disease.Doctor decided to go for surgery which is consisting of anterior cervical microdiscectomy with decompression and artificial disc implantation at c3-c4 and c6-c7 with motion preservation technique and anterior cervical fusion with bone graft and plate at levels c4-c5 and c5-c6.Doctor informed the patient that surgery will be performed at 4 levels but will combine both techniques to avoid long fusion which has a high risk of failure of bone fusion, plate and screws.(b)(6) 2021: patient visited the hospital for preanesthesia evaluation.(b)(6) 2021: patient underwent ecg.(b)(6) 2021: patient had covid-19 (qrt-pcr) testand the result indicates that sars cov 2 is not identified in the patient¿s specimen.(b)(6) 2021: patient underwent anterior cervical microdiscectomy, decompression and arthroplasty c3-4 and c6-7; and fixation for fusion c4-5-6.For anterior cervical microdiscectomy with decompression and artificial disc implantation at c3-c4 and c6-c7 with motion preservation technique and anterior cervical fusion with bone graft and plate at levels c4-c5 and c5-c6.Surgery description/technique/procedure: patient on supine position, checked the level by fluoroscopy, full protection (anti-dvt, ionm, body and face), prep and drape w antisseptic-sterile technique, on tourniquete to elevate the upper back during the acdf anterior left lateral incision w loupe (zeiss 4 x 500 mm), smith robinson surgical approach, exposure c3-4-5-6-7 -confirmed by x-ray, anterior microdiscectomy and removal of osteophytes, change to microscope (zeiss pentero), posterior discectomy and posterior-foraminal decompression c3-4-5-6-7, fine and ionm (intraoperative neuromonitoring) ok, preparation of the disc space, insertion of 2 artificial discs prestige lp (16 x 5 mm) for arthroplasty c3-4 and (16 x 6 mm) for arthroplasty c6-7; x ray ap-lateral was ok insertion of 2 tricotical bone allografts (5 x 12 mm) to replace the disc c4-5-6, fixed with anterior cervical plate and 6 screws (zevo) c4-5-6, locked the plate-screws, revision of the imaged and surgery, no bleeding, looks fine, w good fixation of the implants.Revision of the hemostasis (aquamantys, surgiflo, cotonoid, surgicel), closure by layers, dermabond, drain and dressing.Intraoperative findings: cervical disc disease c3-4-5-6-7 with bilateral foraminal stenosis.Placement of devices/drainages: artificial discs prestige lp = 2 + anterior cervical plate-6 screws zevo (medtronic).Post-operative plan: guidelines after cervical arthroplasty and fusion = hybrid cervical surgery.Com plications: none note: due to size constraint for b5, rest of the additional information will be continued in h10.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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(b)(6) 2021: patient underwent a routine post-surgical x-ray, which showed a problem with the disc prompting the ct scan.Surgeon sent whatsapp images to patient to compare the new x-ray as well as the day one x-ray.Surgeon requested patient for a ct scan.Surgeon said to patient that he is considering removing the artificial disc c6-7 and perform a fusion on that level.Patient asked the surgeon for the estimate time of recovery and the surgeon said that it will be similar to previous surgery.Patient asked the surgeon that how soon the surgery needs to be done.Surgeon replied that it is not urgent, but if there is no medical restriction or any other problem, surgery needs to be done soon.Surgeon informed the patient that artificial disc is not stable enough, that superior part can move forward and potentially cause problem.08 december 2021: patient underwent a ct scan, which showed that the disc was broken.After the x-ray and ct scan results, surgeon informed the patient that another surgery was necessary.
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Search Alerts/Recalls
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