MAUDE Adverse Event Report: SYNTHES HAGENDORF PRODISC-C VIVO UNCEM CONVEX SIZ L 17*14; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 04.670.946S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device history records review was completed for part# 04.670.946s, lot# 8523897.Manufacturing location: (b)(4), manufacturing date: jul 17, 2013, expiry date: jul 01, 2023.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that patient underwent initial implant procedure on (b)(6) 2016.Post-operative, a prodisc vivo migrated anteriorly and was fish mouthing.On (b)(6) 2017, patient underwent a revision surgery on level cervical vertebrae 4/5 due to implant migration.The surgeon was concerned that it was a kinematic issue, instead of a product problem.The patient was therefore fused at this level at the time of revision.All instrumentation was removed correctly from the patient.The surgeon implanted a cfrp cage and skyline plate and screws at the tdr site.It was reported that no adverse event occurred to patient.This report is for one (1) prodisc-c vivo.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6678017
• MDR Text Key: 78768540
• Report Number: 3003875359-2017-10312
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 04.670.946S
• Device Lot Number: 8523897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention