MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-6PLATES; PLATE, BONE

Catalog Number	78-92006
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	07/16/2024
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
It was reported that during surgery, the plates needed adjustment.This caused a surgical delay of 20 minutes.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.The reported event is considered unconfirmed, as no postoperative scans were provided.A patient case involving upc plates required intraoperative adjustments to all six plates, resulting in a 20-minute surgical delay due to issues with guide usability.Investigations confirmed that the plates matched the planned design and met all specifications, with no evidence of device-related failure or malfunction.Based on the investigation, there is no indication of a product malfunction or any design-, material-, or manufacturing-related issue.Therefore, no corrective or preventive actions are deemed necessary at this time.

• Brand Name: FACIAL ID-ORTHOG-6PLATES
• 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: 19977174
• Report Number: 0008010177-2024-00081
• Device Sequence Number: 18258066
• Product Code: JEY
• UDI-Device Identifier: 07613327370867
• UDI-Public: 07613327370867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 78-92006
• Device Lot Number: 2406031002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/13/2024
• 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