MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-2PLATES; IMPLANT

Catalog Number	78-92002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the devices were broken postoperatively.The devices were removed.
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
Additional information: h6.The reported event was confirmed, as the sales representative provided a picture showing the fractured plates after removal.The plates were removed due to loosening and were found to be broken despite the patient following post-operative care instructions and experiencing no trauma.Investigation confirmed that the plates were manufactured according to specifications and matched the original design, but the root cause of the breakage could not be determined.Based on the investigation and corresponding statistical evaluation, there is no indication of an incorrect working product or any systematic design, material, or manufacturing-related issue.Therefore, no further corrective or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: FACIAL ID-ORTHOG-2PLATES
• 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: 20182379
• Report Number: 0008010177-2024-00097
• Device Sequence Number: 21006516
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182305
• 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): 06/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 78-92002
• Device Lot Number: 2303011037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 06/03/2025
• 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