MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Non-union Bone Fracture (2369); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.This report is for one (1) unknown unk - cage/plate: synfix-lr.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Implant/explant date not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers not provided.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: phan k, et al (2018).Effect of smoking status on successful arthrodesis, clinical outcome, and complications after anterior lumbar interbody fusion (alif).World neurosurgery.Volume 110.Pages e998-e1003.(australia).This retrospective study aims to assess the impact of perioperative smoking status on the rates of perioperative complications, fusion, and adverse clinical outcomes in patients undergoing alif surgery.A total of 137 patients who underwent anterior lumbar interbody fusion (alif) for the following indications: degenerative disk disease without radiculopathy, degenerative disk disease with radiculopathy, spondylolisthesis, failed posterior fusion, adjacent-segment disease, and scoliosis requiring correction, were included in the study.There were 65 males and 72 females.The 114 are nonsmokers with a mean age of 57.41 +/- 13.24 while 23 are smokers with a mean age of 53.04 +/-14.67 years.All patients were implanted with a stand-alone polyether ether ketone integral cage devices, specifically the unknown synthes synfix-lr peek integral cage device with 4 diverging intrinsic screws and an anterior locking plate, without anterior tension band plating or posterior instrumentation.Outcome measures included fusion rates, surgical complications, short-form 12, and oswestry disability index.Subsidence was defined as greater or equal to 2 mm mean loss of height.Delayed subsidence was defined as occurring after 6 weeks postoperatively.Follow-up was until 12 months post-op.Complications were reported as follows: one reported patient death.A (b)(6) year old male, treated for degenerative disc disease without radiculopathy, had nonunion at l4-l5 at 10 months post-op.A (b)(6) year old male, treated for degenerative disc disease without radiculopathy, had nonunion at l5-s1 at 12 months post-op.Unknown patients had failed fusion.Three patients had wound infection.Seven patients had pseudarthrosis.One patient had deep vein thrombosis (dvt).Two patients had postoperative ileus.Three patients had postoperative hematoma.One patient had vessel injury.One patient had wound dehiscence.One patient had pneumonia.Fourteen patients had delayed subsidence.This report is for an unknown synthes synfix-lr peek integral cage device.This is report 3 of 8 for (b)(4).

Event Description

This is attachment (1 of 2) for the follow-up literature report for: (b)(4) due to the attachment being too large.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This is attachment (2 of 2) for the follow-up literature report for: (b)(4) due to the attachment being too large.A copy of the literature article is being submitted with this medwatch.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7900143
• MDR Text Key: 121440883
• Report Number: 8030965-2018-56562
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention