MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TITANIUM CONDYLAR HEAD; PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY

Catalog Number 04.449.000S

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, mandible reconstruction surgery was performed.During the surgery, when fixing the unknown plate, the surgeon tried to fix the condylar head and fixation plate with two (2) matrixmandible setscrews, it was reported that the setscrews could not be firmly tightened and the fixation between condylar head and the fixation plate was not firmly fixed.The surgeon replaced the setscrews and reinserted it vertically.However, the fixation of the condylar head and the plate did not improve.The condylar head was still implanted in the patient's body with the condyler head and the reinserted fixing plate moving slightly.The procedure was successfully completed.No plan for re-operation.It was unknown if there was a surgical delay.There was no harm to the patient reported.Concomitant device reported: unknown screwdriver (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) titanium condylar head.This is report 1 of 5 for complaint (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.Device history lot this mre review is for sterilization procedure only part: 04.449.000s, lot: 2l26268, manufacturing site: selzach , supplier: (b)(4), release to warehouse date: 12.November 2018, expiry date: 01.November 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in mezzovico.Part: 04.449.000, lot: l943948, manufacturing site: mezzovico , release to warehouse date: 06.August 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.H10 additional narrative: h4: device history review: this mre review is for sterilization procedure only, part: 04.449.000s, lot: 2l26268, manufacturing site: selzach , supplier: (b)(4).Release to warehouse date: 12.November 2018, expiry date: 01.November 2028, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in mezzovico.Part: 04.449.000, lot: l943948, manufacturing site: mezzovico, release to warehouse date: 06.August 2018, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: TITANIUM CONDYLAR HEAD
• Type of Device: PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8713321
• MDR Text Key: 148547004
• Report Number: 8030965-2019-65480
• Device Sequence Number: 1
• Product Code: NEI
• UDI-Device Identifier: 07611819874145
• UDI-Public: (01)07611819874145
• Combination Product (y/n): N
• PMA/PMN Number: K063181
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.449.000S
• Device Lot Number: 2L26268
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: CMF