MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM; BONE PLATE

Catalog Number 04.511.205.01C

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent a mandible materialise due to sleep apnea.A follow-up ct scan showed that some of the screws of the plate had backed out, there was a likely infection and the mandible had appeared to have moved from its original position.There was massive advancement, well beyond the normal movement case.The revision surgery was performed on (b)(6) 2020.The surgeon advised he will use heavier plates with more fixation moving forward, 1.25mm instead of a 1mm plate.The anterior screws were totally backed out and the posterior screws had pulled through the plate and were in the bone.The patient specific plate was removed and replaced with a standard plate from the matrix mandible plating system.In addition, all of the screws were removed.The surgeon confirmed there was no infection.The patient is still very happy with the surgical outcome.This report is for one (1) 1.85mm ti matrix screw self-tapping/5mm.This report is 8 of 9 for (b)(4).

Event Description

Updated information: all of the anterior screws backed out.Posterior screws no ( not sure of quantity).

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.G5: device is not distributed in the united states but is similar to device marketed in the usa.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: 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9666523
• MDR Text Key: 190545220
• Report Number: 8030965-2020-00829
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819358126
• UDI-Public: (01)07611819358126
• 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
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.205.01C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR