MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-4PLATES; PLATE, BONE

Catalog Number	78-92004
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
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
The plate did not fit as expected.Surgeon used a stock plate instead.
Additional Manufacturer Narrative
Corrected: d9.Additional information: h6.The reported event was confirmed, as the device was returned to stryker.The sales representative confirmed that the surgery using the upc implant under complaint experienced a 15-minute delay due to the use of a stock plate.An analysis by the design team confirmed that the implant was designed as requested, and all quality and manufacturing steps followed the applicable procedures.Although no recent post-op scan is available, the implant fit properly during the pre-delivery fitting test, and the dhr review confirmed it was manufactured to specification.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issues.Therefore, no corrective or preventive actions are deemed necessary at this time.
Event or Problem Description
The plate did not fit as expected.Surgeon used a stock plate instead.

• Brand Name: FACIAL ID-ORTHOG-4PLATES
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 19928806
• Report Number: 0008010177-2024-00077
• Device Sequence Number: 15547236
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193143
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 78-92004
• Device Lot Number: 2406171059
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/07/2024
• 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
• Patient Sex: Unknown