MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-6PLATES; IMPLANT

Catalog Number	78-92006
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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
It was reported that the device did not fit.
Additional Manufacturer Narrative
Correction: b1, b2.Update: h6.The reported event is considered as confirmed.The reported issue was confirmed through post-operative scans, which showed that the patient's maxilla was not positioned as planned during surgery.The patient received facial id plates and tmj implants, but the surgeon had to modify the ramus to properly fit the joints.The sales rep confirmed all splints were used and there were no issues with the guides or plates.An investigation by the engineering and design teams revealed that the final plates matched the original design and manufacturing specifications.3d systems also found no deviations in the planning or manufacturing files.However, the misplacement of the maxilla during surgery was likely due to insufficient removal of patient anatomy during the resection, which affected the maxilla's vertical movement and the fitting of the tmj implants.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.
Event or Problem Description
It was reported that the device did not fit.

• Brand Name: FACIAL ID-ORTHOG-6PLATES
• 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: 20299636
• Report Number: 0008010177-2024-00104
• Device Sequence Number: 8866670
• Product Code: JEY
• UDI-Device Identifier: 07613327370867
• UDI-Public: 07613327370867
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/08/2025

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
• Device Catalogue Number: 78-92006
• Device Lot Number: 2408091042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 05/08/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown