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

Model 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	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the plate did not fit as expected.The surgeon cut the plate to fit the patient.There were no reported adverse events to the patient, no extensive surgery delay reported.
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 during surgery, the plate did not fit as expected.The surgeon cut the plate to fit the patient.There were no reported adverse events to the patient, no extensive surgery delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed as an intra-operative photo was provided.

• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16772420
• Report Number: 0002031049-2023-00019
• Device Sequence Number: 15056990
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 78-92004
• Device Catalogue Number: 78-92004
• Device Lot Number: 2301301008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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