MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, STRAIGHT, DOUBLE STRIP, MP, 2X30 HOLE; IMPLANT

Catalog Number	92-08530
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
It was reported that the hardware was removed.
Additional Manufacturer Narrative
Additional information: h6.Correction: it was determined after receiving further clarification from the customer and the log files from the device, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.The devices were removed due to fistulae following an orthognathic jaw surgery performed earlier, with proper sterilization confirmed by the sales rep.The surgeon did not attribute the fistula to the devices, and stryker's medical expert concluded that the devices did not cause or contribute to the issue (see communication log).
Event or Problem Description
No new information.

• Brand Name: PLATE, STRAIGHT, DOUBLE STRIP, MP, 2X30 HOLE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 22052306
• Report Number: 0008010177-2025-00078
• Device Sequence Number: 8908350
• Product Code: JEY
• UDI-Device Identifier: 07613327485684
• UDI-Public: 07613327485684
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 92-08530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown