MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/6HL CVD SAG SPT12MMBAR LOK; IMPLANT

Catalog Number	55-10556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
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 sagittal plate implanted on the left side of the mandible was broken at the anterior medial screw hole.
Additional Manufacturer Narrative
Additional information: d6a, d6b, h4, h6.The reported event could not be confirmed, as the device was not returned for investigation and no images of the device or x-rays were available.The plate was implanted, all broken fragments were retrieved, and due to multiple plates and screws used in a bilateral fracture, it was not possible to link specific screws to specific plates; despite several requests, the device was not returned for investigation.Review of manufacturing and inspection records found no issues related to the reported event.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: PLT/6HL CVD SAG SPT12MMBAR LOK
• 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: 23554101
• Report Number: 0008010177-2025-00158
• Device Sequence Number: 15992615
• Product Code: JEY
• UDI-Device Identifier: 04546540366252
• UDI-Public: 04546540366252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: Yes
• Device Catalogue Number: 55-10556
• Device Lot Number: 1000535760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: Other
• Patient Sex: Unknown