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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Inflammation (1932); Pain (1994); Swelling (2091); Stenosis (2263); Numbness (2415)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision surgery at l5-s1 in which rhbmp-2/acs was used.Bmp was also placed in the lateral recesses and transverse processes.Reportedly, sometime post-op, the patient developed severe back pain.The patient experiences daily, disabling pain that prevents him from performing many basic activities.
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Event Description
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Pt demographics: current: (b)(6).The surgical approach used: transforaminal lumbar interbody fusion (tlif) and posterior lumbar interbody fusion (plif) it was reported that on (b)(6) 2010: patient underwent revision of fusion surgery and was also implanted with allograft matrix, replacement hardware due to diagnosis of back pain.Post-op rhbmp-2/acs treatment, patient alleged and still continue of having chronic pain and swelling at the fusion site, inflammation at the fusion site that causes stiffness in moving around, and numbness in his back and right side.Patient complained of having discomfort at all times with back pain and other symptoms continued after each surgery and got worsened over time.Patient reported that he's no longer able to participate in any physical activities like snowboarding, hiking, climbing.In year 2009-2010 and year 2012-2014, on unknown dates patient presented with diagnosis of back pain.For which patient also underwent for imaging studies.On (b)(6) 2015: patient underwent appendix removal procedure.On an unknown date patient underwent l5-s1 fusion.(b)(6) 2012: patient presented with dorsal left 3rd mcp joint pain, swelling and redness.Patient underwent left hand x-ray which showed no fracture or dislocation.Post splinting neurovascular exam was normal.Diagnosis: dorsal left 3rd mcp pain/swelling/erythema; strain vs cellulitis.(b)(6) 2012: patient underwent mandible x-ray due to pain and status post trauma.(b)(6) 2013: patient presented with complaints of fb/fb sensation to his right eye that started 2 days pta when he got something in his right eye while grinding metal underneath his car.Patient noted blurry vision to his right eye, right eye redness and tearing.Diagnosis: 1.Right inferomedial (nasal) corneal foreign body/abrasion.2.Elevated blood pressure ¿ r/o hypertension.(b)(6) 2013: patient presented for eye check up.Patient reported improving redness, no swelling drainage or systemic symptoms.No visual blurring, only slight discomfort.(b)(6) 2013: patient underwent ct lumbar spine without contrast due to indications of back pain/previous surgery.(b)(6) 2014: patient underwent mr lumbar spine without gadolinium due to indication of lumbar radiculopathy.(b)(6) 2009 the patient underwent x-rays of the lumbar spine.(b)(6) 2009 the patient presented with the complaint of low back pain form l5-s1, isthmic spondylolisthesis.He also had deep discomfort within his pelvis as well as low back that worsens with bending forward.On examination, there was increased pain with forward flexion.Impression: patient continued to have low back pain and perceived instability after 5 years of nonoperative management of his grade i isthmic spondylolisthesis at l5-s1.(b)(6) 2010 on a telephonic encounter, the patient stated that he continued to have pain in his right lower extremity.On (b)(6) 2010: the patient presented with the complaint of right sided low back pain despite previous l5-s1 spondylolisthesis operative management and left low back pain, numbness and tingling.The patient has elicited pain with lumbar extension.The ct scan reports indicate hardware impacting the facets joints, specifically at the l5 level.Impression: the patient is experiencing right greater than left low back pain as a result of symptomatic placement of the right l5 screw which is currently impacting the facet joint at this level.(b)(6) 2010 the patient presented with the pre op diagnosis of painful instrumentation, l5-s1; incomplete fusion, l5-s1.The patient underwent the following procedures: removal of right transpedicular instrumentation, l5-s1, with replacement of left l5 pedicle screw and revision of posterolateral fusion, l5-s1 with bmp and allograft bone.Per the op notes, on the left side, the transverse process of l5 and sacral ala were decorticated and a combination of ½ pack of a small bmp with 5 cc of allograft matrix was laid into the lateral recess.Then on the right side, the transverse process of l5 and sacral ala were decorticated and other half of the bmp as well as 5 cc of demineralized bone matrix was placed into lateral recess.Intra operative fluoroscopy was utilized.No patient complications were reported.On (b)(6) 2010: the patient presented with a history of revision of lumbar fusion hardware and underwent x-rays of the lumbar spine.(b)(6) 2010 the patient was discharged from the hospital.Final diagnosis: symptomatic right l5 screw causing right sided low back pain.
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Manufacturer Narrative
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(b)(6).(b)(4).Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that on: on (b)(6) 2009: the patient underwent lumbar spine x-ray.Impressions: hardware providing fusion to l5-s1 stabilizing an anterior subluxation due to spondylolysis at l5-s1.On (b)(6) 2010: the patient underwent lumbar spine ct scan.Impressions: fusion of a spondylolisthesis secondary to spondylolysis; question of a right partial laminectomy at l5; there is no evidence of nerve root involvement throughout the lumbar spine.On (b)(6) 2010 patient underwent x-ray of the lumbar spine.Findings: images demonstrate removal of the left-sided l 5 -s 1 pedicle screws.Right-sided pedicle screws are still present.On (b)(6) 2011: the patient underwent lumbar spine x-ray.Impressions: surgery lower lumbar spine; no acute bony abnormalities.On (b)(6) 2012: patient underwent mandible x-ray due to pain and status post trauma.Impression: no acute displaced fracture is identified.Per the billing records, the patient also underwent x-rays of cervical and lumbosacral spine.Impression: straightened cervical spine may be secondary to myospasm; no acute displaced fracture is identified; mild disc disease, c5-6 and c6-7 and urinicate hypertrophy at c5- c6.Patient underwent x-ray of the lumbar spine.Impression: mild thoracolumbar dextroscoliosis; straightened lumbar spine may be secondary to spasm; grade 1 anterolisthesis of l5 over s1; degenerative changes.On (b)(6) 2015: the patient visited the facility for laparoscopic appendectomy with acute appendicitis.Findings: there was a small amount of purulent material immediately adjacent to the base of the appendix.The patient underwent ct abdomen/pelvis w/ contrast impressions: acute retrocecal appendicitis without demonstrable free perforation or abscess formation.On (b)(6) 2015: the patient presented with quadrant abdominal pain.Per the medical records ct scan demonstrated evidence of appendicitis with periappendiceal inflammation.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, (b)(6) 2012: patient presented for an office visit with chief complaints of sinus symptoms (chronic) and depression.Associated symptoms include difficulty breathing, headache, hoarseness, nasal congestion, nasal drainage, postnasal drainage and sinus pressure.The review of system revealed that the patient is positive for difficulty breathing and headache.On (b)(6) 2012: patient presented at dental office with complaint of cracked #8 crown.On (b)(6) 2012: patient presented with medication renewal request.
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Manufacturer Narrative
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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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It was reported that on: (b)(6) 2008: on a telephonic encounter patient stated that range of motion is improved and felt significant relief of his low back pain.On (b)(6) 2009: on a telephonic encounter patient stated that the patient had pain over the weekend and continues to have a pressure sensation when he flexes and extends his low back.On (b)(6) 2012: the patient presented for follow up of injuries and for onset of respiratory infection.The patient continued with milder soreness of posterior neck and right hip.The patient had several days of nasal congestion; felt hot and cold first, had sinus pressure, sight cough.The patient reported chronic left greater than right nasal congestion.On (b)(6) 2013: the patient presented for follow up visit for back pain.On (b)(6) 2013: the patient presented for follow up visit for back pain at surgery site achy pain all day, right leg pain, stiffness when bending.On (b)(6) 2013: the patient presented for lab follow-up visit.On (b)(6) 2014: the patient presented with a chief complaint of poss splinter in right foot for 2 weeks.On (b)(6) 2014 per billing records, patient underwent ct scan of l spine post myelogram.Impressions: no significant neuroforaminal narrowing or spinal canal stenosis; moderate bilateral neuroforaminal narrowing at l4-l5.Impressions: successful fluoroscopy guided intrathecal contrast administration.On (b)(6) 2014: the patient presented for follow up for low back pain and right leg pain.On (b)(6) 2014: the patient presented for follow up visit for worsening back pain.On (b)(6) 2013: the patient presented to evaluate her ongoing treatment program and pain complex.She has required treatment for low back pain, pain into both lower extremities.On (b)(6) 2013: the patient presented with concerns about lyme disease.She had some swelling in her knee and ankle.Assessment: history of possible tick exposure; hypothyroidism; history of abnormal mole.On (b)(6) 2013: the patient presented with knee swelling and pain.She gained about 40 pounds over the last two years.Assessment: monoarthritis of knee; chronic pain syndrome; arthralgia.On (b)(6) 2013: the patient presented for follow-up.Assessment: skin flushed (782.62); pneumonia, organism unspecified (486).She underwent x-ray of chest.On (b)(6) 2013: follow up on knee swelling and pain.The patient returns for follow up, seen on (b)(6) 2013 for monoarthritis of the left knee.She was given an injection with triamcinolone acetate.She stated that the next day she developed significant flushing of her face and anterior chest, no wheezing, chest pain, cough, tongue or lip swelling.Since her left knee swelling and pain has significantly improved.She denies any swelling today.Assessment: swelling of right knee joint; adverse drug reaction.On (b)(6) 2013: the patient presented to evaluate her ongoing treatment program and pain complex.She has required treatment for low back pain, pain into both lower extremities.She suffers from fibromyalgia and chronic fatigue syndrome.She has pain in both hips.On (b)(6) 2013: the patient presented with evaluation of some changing moles on her trunk and face.On (b)(6) 2013: follow up on knee swelling.She stated that since her last visit, the left knee has been progressively swelling slowly over the last one month.She noted pain especially with walking, crouching down or when up and down steps.On (b)(6) 2014 per billing records, patient underwent ct scan of lumbar spine post myelogram.On (b)(6) 2014: the patient underwent left knee arthroscopic procedure.On (b)(6) 2014: after 14 days of left knee arthroscopy pmm, pain was controlled with current analgesics.Post op problems were reported: none.On (b)(6) 2014: the patient presented for follow up.Her chief complaint was right-sided low back pain that is extended into the buttock region.On (b)(6) 2014: the patient presented for post op follow up at the 6 week mark after surgery.She continued to have quite severe axial back pain.Assessment: ongoing symptoms.On (b)(6) 2014: the patient presented for evaluation of possible bug bites to her upper thighs, buttocks and under her bilateral breast areas.She noted that the sores were itchy.She instructed to take cetirazine daily and discharged ambulatory and in stable condition.On (b)(6) 2014: the patient presented with the problem of cough from 5 days and fever today.She underwent copd exacerbation (hcc) but no obvious infiltrate were observed on the x- ray.She had given some medicines.On (b)(6) 2014: the patient was presented with cough as a chief complaint.Clinical impression: viral syndrome.On (b)(6) 2016: the patient presented with low back and right leg pain.Patient¿s lower back pain was getting worse and chronic.Patient was also suffering from the following: radicular pain, posterior aspect of lower extremities of top of outer thigh, leg pain, pain localized to one or more joints upper and lower back pain, pain in between shoulder blades that was sharp and frequent, pain in low back radiating down the back of his right buttocks.The pain was sharp, shooting and constant and was worse when lifting his leg.The patient underwent frontal, lateral and spot view of the lumbar spine.Impressions: high suspicion of loosening of the left l1 screw.The patient underwent thoracic spine with swimmers views.Impressions: no acute findings.No fracture; mild degenerative disc disease of the lower thoracic spine.
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