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

Catalog Number	78-92004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
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 left facial id plate was fractured.
Event or Problem Description
It was reported that the left facial id plate was fractured.
Additional Manufacturer Narrative
Correction: b1, update: h6.The reported event is considered as confirmed as it was confirmed by a picture provided by the sales representative, showing a fractured plate matching the left bsso plate in the design proposal.It is unclear whether the patient followed post-operative care instructions, experienced trauma, or had related diseases.All components were stable upon removal, and the plate did not require replacement.The complaint analysis, conducted by the stryker design engineer, found no deviations, and the manufacturing records confirm the device was made according to specifications.As a result, the root cause of the plate breakage remains undetermined.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.The complaint is added to the complaint trend.

• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 20125071
• Report Number: 0008010177-2024-00092
• Device Sequence Number: 7398572
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/21/2025

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
• Device Catalogue Number: 78-92004
• Device Lot Number: 2310121054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 05/21/2025
• 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