MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIALID-MAXILLOFACIAL-1MESH; IMPLANT

Catalog Number	78-94001
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant(s) did not function according to its intended purpose, and the patient underwent reoperation.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Update: h6.The incident could not be confirmed.However, in a retrospective examination, the surgeon reported that the custom-made orbital floor implant had shifted posteriorly during screw fixation due to its bulky anterior edge, requiring reoperation on the same day and replacement with a less bulky, pre-curved implant.The investigation confirmed that the implant met the surgeon's specifications and that the low placement of the screw holes indicated by the surgeon may have contributed to the elevation of the posterior plate.Based on the investigation, there are no indications of incorrectly working product or problems related to design, material, or manufacturing.Therefore, no corrective and/or preventive measures are considered necessary at this time.
Event or Problem Description
No new information.

• Brand Name: FACIALID-MAXILLOFACIAL-1MESH
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23324489
• Report Number: 0008010177-2025-00134
• Device Sequence Number: 21316734
• Product Code: JEY
• UDI-Device Identifier: 07613327556285
• UDI-Public: 07613327556285
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 78-94001
• Device Lot Number: 2505081015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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