MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-3PLATES; IMPLANT

Catalog Number	78-92003
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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
Inconsistency between guides and manufactured plate has led to difficulties while plating.
Event or Problem Description
Inconsistency between guides and manufactured plate has led to difficulties while plating.
Additional Manufacturer Narrative
Corrected: b1 additional: h6 as per information received, the device in question is considered concomitant.It did not cause or contribute to the reported event.3ds also performed an investigation.The result of their investigation stated that the root cause of this complaint was a failure by the case planner to accurately document the intended drill hole size.The planner for this case was spoken to and assigned a re-training.

• Brand Name: FACIAL ID-ORTHOG-3PLATES
• 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: 20451441
• Report Number: 0008010177-2024-00111
• Device Sequence Number: 7007937
• Product Code: JEY
• UDI-Device Identifier: 07613327370775
• UDI-Public: 07613327370775
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/23/2025

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: 78-92003
• Device Lot Number: 2407021060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 05/23/2025
• 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: Hospitalization
• Patient Sex: Unknown