MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLE; PROSTHESIS, CONDYLE, MANDIBULAR TEMPORARY

Catalog Number 04.497.001

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device has not been reported as explanted.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.A review of the device history records has been requested.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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2018 a two (2) titanium condylar heads and a slotted screw for conylar head did not fit properly with the patient specific plate for mandible.The surgeon noticed from his last surgery that there was an offset between the plate and the condylar head after fixation with the screws.The screws only did a small rotation to be locked in their position, hence the plate was not well in contact with the condyle.There was no surgical delay reported and did not cause injury or harm to the patient.This report is for a slotted screw.This is report 2 of 4 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history: device history.Part: 04.497.001.Lot: 9963924.Manufacturing site: mezzovico.Release to warehouse date: 31.May 2016.A manufacturing record evaluation was performed for the finished device 04.497.001 with lot number 9963924 and no non-conformances were identified.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.Product was not returned.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.

• Brand Name: SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLE
• Type of Device: PROSTHESIS, CONDYLE, MANDIBULAR TEMPORARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8289331
• MDR Text Key: 134507988
• Report Number: 8030965-2019-60488
• Device Sequence Number: 1
• Product Code: NEI
• UDI-Device Identifier: 07611819326484
• UDI-Public: (01)07611819326484
• Combination Product (y/n): N
• PMA/PMN Number: K081747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.497.001
• Device Lot Number: 9963924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1