MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-3PLATES; PLATE, BONE

Catalog Number	78-92003
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	04/12/2026
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 patient complained of itchiness in the area of the le fort i osteotomy.X-rays showed 2¿3 loose screws, and the hardware will be removed.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The reported allergic reaction could not be confirmed as allergy test results were not provided for review.Follow up information indicated that the patient experienced itchiness and red gums approximately one year after implantation.Although screw loosening was suspected by the surgeon, this could not be confirmed as postoperative x rays were not available for evaluation.The devices remain implanted, and hardware removal is being considered.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.

• Brand Name: FACIAL ID-ORTHOG-3PLATES
• Common Device Name: PLATE, BONE
• 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 gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 25110952
• Report Number: 0008010177-2026-00064
• Device Sequence Number: 9219176
• Product Code: JEY
• UDI-Device Identifier: 07613327370775
• UDI-Public: 07613327370775
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Device Catalogue Number: 78-92003
• Device Lot Number: 2411101003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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