MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-2PLATES; IMPLANT

Catalog Number	78-92002
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	08/08/2024
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
It was reported that during surgery, the plate did not fit.
Event or Problem Description
It was reported that during surgery, the plate did not fit.
Additional Manufacturer Narrative
Update: h6.The event is considered confirmed and occurred during surgery where the left maxillary fixation plate could not be used due to an unplanned maxilla advancement.The surgeon had to use stock l-plates, leading to a delay of 15-60 minutes.The cause of the issue was unclear, possibly related to splints, guides, or the plate itself, and no post-op ct was available.Stryker's custom design team analyzed the complaint and found no discrepancies in the design or manufacturing of the plates.The plates were made according to the specifications provided by 3d systems.The investigation regarding the splints, guides, and vsp (virtual surgical planning) is being handled by 3d systems and documented separately.Without a post-op scan or additional information, the root cause of the event 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-2PLATES
• 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: 20140889
• Report Number: 0008010177-2024-00095
• Device Sequence Number: 20698485
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/09/2025

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: 78-92002
• Device Lot Number: 2407031058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 05/09/2025
• 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