MAUDE Adverse Event Report: SYNTHES USA; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that the cage migrated post-op, no prolongation in surgery this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown acid cage/unknown lot number.Unknown implant or explant date without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An x-ray investigation summary was performed.The investigation of the complaint articles has shown that: since the concerned aci-implant was not returned for analysis and the exact article and lot number is not known the present complaint cannot be fully analysed and we are not able to give a conclusive statement regarding a possible failure reason.The review of the x-rays (date unknown) revealed that the cage is partially migrated anteriorly.But we are not able to give a conclusive statement regarding a possible failure reason.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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4865370
• MDR Text Key: 6041955
• Report Number: 2520274-2015-14583
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1