MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.510k: this report is for an unknown synfix cage/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant/explant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone not available for reporting.Without a lot number the device history records review could not be completed.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: lee n, et al (2017).Comparison of outcomes of anterior, posterior, and transforaminal lumbar interbody fusion surgery at a single lumbar level with degenerative spinal disease.World neurosurgery.Volume 101.Pages 216-226.((b)(6)).The aim of this retrospective study was to compare the radiologic and surgical outcomes, including fusion and cage subsidence rates, between different fusion techniques in patients with degenerative spinal stenosis and instability on a single level, l5-s1.It also assessed how much sagittal alignment correction is obtained with each surgical technique and the incidence rate of adjacent segmental disease (asd).Between february 2007 and november 2013, a total of 77 patients who underwent lumbar fusion surgery to treat spondylolytic spondylolisthesis on l5-s1 or degenerative lumbar spinal stenosis on l5-s1, were included in the study.There were 16 men and 61 women with a mean age of 56.1 years (range, 20 to 80 years).Anterior lumbar interbody fusion (alif) was performed on 26 patients and they were implanted with an unknown synthes synfix cage packed with allograft.Clinical outcome was measured with a visual analog scale (vas) for low back pain preoperatively and at the last follow-up.Fusion rate was evaluated with computed tomography (ct) scan taken at 1 year after surgery.If ct showed an incomplete fusion at 1 year post-op, another ct scan was taken again at 2 years after surgery.Only fusion grade 1 was regarded as successful fusion on ct scan.Segmental rom was also used to assess fusion state; a segmental rom greater than 4 degree was regarded as non-fused while below 4 degree was regarded as fused.Cage subsidence, defined as any breakage of the endplate, either upper or lower, and migration of the cage into the vertebral body, was evaluated at 1 and 2 years post-op on ct scan or plain radiographs.The mean follow-up period was 21.6 months (range, 12 to 84 months).Complications were reported as follows: two patients developed asd, 1 required operation.One patient had persistent radiating pain.One patient had recurrent lower back pain.One patient had iliac vein injury.Ten patients had incomplete fusion at 1 year post-op by ct scan.Four patients had incomplete fusion at 2 years post-op by ct scan.Two patients had incomplete fusion at 1 year post-op by segmental rom on radiographs.This is report 1 of 2 for (b)(4).

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.Additional narrative: event: pages 221 - 226 part 2, follow-up 2 of the literature article is attached, the previous follow up (1).Part 1 pages 216 - 220 submitted.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 is report 1 of 2 for (b)(4).A copy of the literature article pages 221 - 226 is being submitted with this medwatch.

Event Description

This is report 1 of 2 for (b)(4).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.Literature article is being attached from previous mw submitted.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).

• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7885686
• MDR Text Key: 120574267
• Report Number: 8030965-2018-56424
• 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: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• 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: 09/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention