MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Blood Loss (2597)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient underwent spinal surgery from l2-s1 due to stenosis with documented pre-operative instability.Post-op, the patient had possible left l5 lle radiculopathy.

Manufacturer Narrative

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.

Event Description

Type of spinal surgery: disectomy primary diagnostic indication: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis); all other diagnostic indications: stenosis with documented pre-operative instability.Target levels: l4-l5 & l5-s1; total estimated blood loss: 300 ml; surgical drain used- yes; barrier (e.G., fibrin sealant, fat graft) used as part of the study procedure- yes; type of barrier was used: duraseal.Level placed: left l5 root, central dura; tlif at l5/s1 the start date was reported as 15-sep-2019.As of today(05 dec 2019), the outcome for l2-l3 disc herniation with associated stenosis and radiculopathy is pending/ongoing/unresolved.

Manufacturer Narrative

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.

Event Description

Patient demographics:patient clinical id (b)(6); gender female; age: 63 years (at the time of event); patient weight:90 kg; race: white; ethnicity not hispanic or latino medical history:lumbar surgery.Date of surgery: (b)(6)2017 type of spinal surgery: disectomy levels(s): l2/l3 details: microlumbar disectomy primary diagnostic indication: stenosis with documented pre-op instability the subject had treated: 2 levels (from l2-s1) date of implant: (b)(6)2019 it was reported that on (b)(6)2019, post-op, the patient had possible left l5 lle radiculopathy.Onset date: (b)(6)2019 outcome status: pending.Site seriousness assessment: sae: n uade: n site related assessment: interbody fusion device:not related plf grafting material other:not related posterior fixation device:not related surgical construct and/or study procedure :other: not related surgical procedure :procedure:not related update: (b)(6)2019: date of last visit: (b)(6)2019, sponsor assessment: seriousness: non-serious usade/uade assessment : no dd have led to sade: not applicable.Infuse kit: possible interbody device: not related mgs kit: possible multiaxial screws: not related procedure: possible rods: not related set screws: not related surgical procedure: possible update received on 09 aug 2019: medications: the only concomitant medications collected are pain medications.Below is the preoperative (visit date: (b)(6)2019) concomitant medications pain medications data: ibuprofen (motrin, advil), naproxen (aleve), aspirin, or acetaminophen (tylenol)- rarely (1-2 day a week) celebrex or gabapentinoids (neurontin or lyrica)- often (nearly every day, 6-7 days a week) below is the 3-month (visit date: (b)(6)2019) concomitant medications pain medications data: celebrex or gabapentinoids (neurontin or lyrica)- often (nearly every day, 6-7 days a week) tylenol 3, darvocet, darvon, vicodin, lorcet, or norco)- often (nearly every day, 6-7 days a week) primary diagnostic indication: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis); all other diagnostic indications: stenosis with documented pre-operative instability past medical history: pulmonary embolism; hypothyroidism; bilateral hip replacement - 2011; congenital spondylolisthesis; right carpal tunnel surgery - 02/21/19; left knee replacement - 2013; bilateral knee osteoarthritis; possible gout; possible fibromyalgia; chronic low back pain; bilateral lower extremity pain (right >left); vertigo; anxiety and depression; ckd3; l2/l3 microlumbar discectomy on (b)(6)2017.Date of surgery: (b)(6)2019; start time: 13:25; stop time: 16:31; treatment group: group 1 - infuse 4.2 + mastergraft + local bone; target levels: l4-l5 l5-s1; total estimated blood loss: 300 ml; was a surgical drain used? yes; was a barrier (e.G., fibrin sealant, fat graft) used as part of the study procedure? yes; what type of barrier was used?: duraseal; level placed: left l5 root, central dura; tlif at l5/s1 treatment required for event: drug therapy (unspecified) <(>&<)> physical therapy apart from radiculopathy patient also suffered from post-op nausea.Update received on 17 oct 2019: pregnant since last visit 6_months: has the subject become pregnant since last visit: no date of visit: (b)(6)2019 update received on 06 nov 2019: surgical intervention: yes additional surgery- additional surgical procedure: laminectomy with posteriolateral fusion at l2-l4 and microlumbardiscectomy at l2-l3 levels involved in the additional surgical procedure: l2/l3, l3/l4 additional surgical procedure to surgical construct and/or the study procedure - not related further update received on 06 nov 2019: patient demographics: age: 63 years and 5 months (at the time of informed consent).Relevant patient medical history, including pre-existing conditions: pulmonary embolism;hypothyroidism; bilateral hip replacement - 2011, congenital spondylolisthesis, right carpal tunnel surgery on 21 feb 19; left knee replacement in 2013; bilateral knee osteoarthritis; possible gout; possible fibromyalgia; chronic low back pain; bilateral lower extremity pain (right >left).; vertigo; anxiety and depression; ckd3.Primary diagnostic indication: instability (upto and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis).All other diagnostic indications: stenosis with documented pre-operative instability.Previous surgeries: patient had previous lumbar spinal surgery (including target and adjacent target level surgeries) discectomy on (b)(6)2017 l2/l3: microlumbar discectomy procedure: posterior lumbar fusion (plf) with l5-s1 tlif levels implanted: l4-l5 l5-s1 (index target levels) date of second implant: (b)(6)2019 event date: (b)(6)2019 event occurred: post-operative this patient¿s original case was a 2 level l4-s1.On (b)(6)2019 infuse 4.2mg/level was used.Patient developed a herniated disc 2 levels above and struggling with back pain and leg pain about 4 to 6 weeks after a primary surgical intervention from l4 to s1 for stenosis, spondylolisthesis and radiculopathy, she had some bending, lifting and twisting activities, her back and leg pain recurred and become very severe.She was evaluated with mri and there was a concern for a disk herniation at l2-l3 with central and subarticular stenosis, compression of the descending l3 nerve roots as well as the dura at l2-l3 above from her former fusion at l4 to s1.The patient felt very strongly that her back and leg symptoms were unresponsive to nonsurgical care and she wanted to consider a surgical intervention.There were no immediate complications.Estimated blood loss was 700 ml.Additional procedure- decompression, fusion l2-l4.Secondary procedure was considered by the surgeon not to be related to the surgical construct/ study procedure.So not related to: 1) the plf grafting material, 2) posterior fixation, 3) interbody fusion.Surgical procedure related is unlikely.On (b)(6)2019 surgeon remove the previous 2 rods and 6 set screws but did not remove any fusion tissue or pedicle screws from the previous procedure.The pictures looked good with fusion in the gutters.He was pleased with the progress there.Elective removal due to the additional levels needed for posterior fixation.The new grafting material at l2-l4 in the posterolateral space (gutters) was local bone with some allograft chips in the ¿beds¿ with infuse on acs sponge (6mg/level, opened large 12mg kit) with grafton matrix (boats) with added screws and new rods.Procedure went well.No fragment of the device remaining in the patient.Update received on 12-nov-2019: hospital discharge summary was provided: date of admission: (b)(6)2019 date of discharge: (b)(6)2019 pre-procedural diagnosis: neurogenic claudication, lumbar degenerative disk disease, lumbar disk herniation.Post-procedural diagnosis: neurogenic claudication, lumbar degenerative disk disease, lumbar disk herniation.On the day of admission, the patient underwent the successful performance of an l2-l4 decompression with posterolateral fusion with l2-l3 microlumbar diskectomy, and revision of rods from l4 to s1.The patient tolerated the procedure well and recovered in the post anesthesia care unit.She was subsequently admitted to the orthopedic service.The patient's pain was initially controlled with iv dilaudid and she transitioned to oral percocet and tolerated this medication without concern.She did not have concerns for nausea or dizziness during her hospital stay.The patient's dressing remained clean, dry and intact.Her foley catheter was discontinued on postoperative day #1.Her hemovac drains were discontinued on postoperative day #2.The patient was evaluated by physical therapy and she ambulated well with assistance.The patient was evaluated by case management, who helped arrange home health services including home physical therapy for the patient.Dvt prophylaxis was maintained with ted stockings, scds, and oral aspirin.Ap and lateral radiographs of lumbar spine were obtained, which demonstrated appropriate placement of screws at l2, l3, l4, 15, and s1 in appropriate placement.The patient was ultimately discharged to home in stable condition on postoperative day #3.The patient will have home health nursing as well as home health physical therapy.The patient will have a follow-up appointment at indiana spine group carmel in 10 to 14 days following discharge.Homegoing medications include percocet and aspirin.Homegoing dvt prophylaxis includes ted stockings and aspirin.The patient was provided with written and verbal discharge instructions.Update received on 05 dec 2019: according to the additional surgical procedure case report form, these 2 adverse events were associated with the surgical intervention/additional surgery: event date- (b)(6)2019: lle radiculopathy- possible left l5 radiculopathy resulting in surgical operation of l2-4 laminectomy with posterolateral fusion and l2-3 event date- (b)(6)2019: microlumbardiscectomy l2-l3 disc herniation with associated stenosis and radiculopathy- right lower extremity pain similar to pre-op but now worsened secondary to l2-l3 disc herniation with associated stenosis the start date was reported as (b)(6)2019.As of today, the outcome for l2-l3 disc herniation with associated stenosis and radiculopathy is pending/ongoing/unresolved the investigator¿s assessment of relatedness to procedure/device was not related.Update received on 10 dec 2019: site seriousness assessment- medical intervention- yes update received on 17 aug 2020: usade/uade assessment: no pregnant since last visit 12_months: the subject become pregnant since last visit: no date of visit: (b)(6)2020, additional information received states that adverse event document numbers associated with additional surgery: document number: r68752905 subevent number: 5 describe the additional surgical procedure: c2-3 down to including c7-t1 decomprassion via c3-7 laminectomy levels involved in additional surgical procedure: non-target/non-lumbar level specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: not related usade/uade assessment: no, could dd have led to sade: not applicable (b)(6)2020 additional information received states that adverse event document numbers associated with additional surgery: document number: (b)(4) subevent number: 8 describe the additional surgical procedure: incision and drainage posterior cervical spiine with placement of wound vac levels involved in additional surgical procedure: non-target/non-lumbar level specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: not related usade/uade assessment: no, could dd have led to sade: not applicable (b)(6)2020: additional surgical intervention was due to cervical spondylotic myelopathy, which is ae document # (b)(4), subevent # 5.Subject presented to the office with symptoms of upper extremity numbness and tingling, neck pain, and hyperreflexia upon neurological examination.Cervical mri demonstrates cervical cord myelomalacia at c3, c4-5, and c6-7., multilevel congenital cervical stenosis, multilevel signigicant facet spondylosis.Assessed as not related to surgical construct and/or study procedure.Outcome reported as resolved with resolution date (b)(6)2020.The site did not report using infuse.Assessed as not related to surgical construct and/or study procedure.C2-3 down to including c7-t1 decomprassion via c3-7 laminectomy.Assessed as not related to surgical construct and/or study procedure.Reporter assessment for the c2-3 down to including c7-t1 decompression via c3-7 laminectomy.Reporter assessment = not related to surgical construct and/or study procedure.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8849458
• MDR Text Key: 152895466
• Report Number: 1030489-2019-00842
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (y/n): N
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 7510200
• Device Lot Number: M111814AAH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 90