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 Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.It is unknown when the event occurred.This report is for three (3) cages or plates - unknown lot; unknown part.Udi number is unknown.Implant date: unknown.There is no indication that the device was removed.Complainant part has not been returned for manufacturer review/investigation.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 subsequent review of the following literature article: yu wang et.Al (2017) anterior discectomy could still be an alternative to corpectomy in highly migrated cervical disc herniation, british journal of neurosurgery, volume 31:6, pages 709-713, (b)(6).The aim of this article is to analyze the feasibility of anterior cervical discectomy and fusion (acdf) for patients with highly migrated cervical disc (hmcd) herniation.For cases where acdf is not feasible, anterior cervical corpectomy and fusion (accf) was performed.A total of 32 patients (18 male and 14 female, ranged from 42-80 years with a median age of 61.7 years) with hmcd treated with acdf or accf were retrospectively reviewed between january 2009 and november 2015.27 were treated with acdf and 5 were treated with accf.Three (3) patients had transient or long-term dysphagia post-operatively (accf group).No malfunction was reported.This complaint involves three (3) devices.This is report 1 of 3 for (b)(4).This report is for an unknown cage or plate.

Manufacturer Narrative

Literature article was inadvertently not attached during initial reporting (mwr-(b)(4)).Article is attached now.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.The product was not returned.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 was inadvertently not attached during initial reporting (mwr-26022018-0000063262) and follow-up report (mwr-04042018-0000086286).Article is attached now.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.- attachment: [(b)(4) wang et al., 2017 (1).Pdf].

• 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: 7338533
• MDR Text Key: 102387662
• Report Number: 8030965-2018-52058
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention