MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-4PLATES; IMPLANT

Catalog Number	78-92004
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that secondary surgery needed to redo bilateral sagittal split osteotomy.
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
No new information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, d9, h3, h4, h6.Device evaluation: follow-up report submitted to document the results of the device evaluation.The reported event could not be confirmed because no postoperative ct scans were submitted.However, the removal of the plates was confirmed by the return of the plates to stryker freiburg.Following orthognathic surgery with facial id plates, two plates were removed and the bsso was repeated due to postoperative occlusal malalignment after removal of the splint, but no postoperative imaging data was available for further evaluation.Reviews of the design, manufacturing, and dhr by stryker and 3d systems revealed no inconsistencies, and without additional clinical data, the cause of the occlusion problem cannot be determined.Based on the investigation, there are no indications of a malfunctioning product or a problem related to the design, material, or manufacturing.Therefore, no corrective and/or preventive measures are considered necessary at this time.

• Brand Name: FACIAL ID-ORTHOG-4PLATES
• 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: 23133686
• Report Number: 0008010177-2025-00119
• Device Sequence Number: 18621009
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 78-92004
• Device Lot Number: 2507241030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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