MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG - MHRA ORG ID:31814 FACIAL ID-ORTHOG-4PLATES; IMPLANT

Catalog Number	78-92004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
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.H3 other text: device remains implanted.
Event or Problem Description
It was reported that it was discovered post operative, the implanted maxillary plates are broken.
Event or Problem Description
It was reported that it was discovered post operative, the implanted maxillary plates are broken.Revision surgery was performed to remove and replace device.
Additional Manufacturer Narrative
Update: h6.Corrected data: b1, b2, b5, d9, h1, & h3.Device was returned for evaluation.The reported event of broken plates could be confirmed: 3 of the returned plates show fractures.All relevant quality documents (manufacturing and inspection documents) have been reviewed.No issues could be found in the manufacturing or inspection documents.Based on the investigation and the corresponding statistical evaluation, there is no indication for an incorrectly working product or any design, material or manufacturing related issue.The complaint is added to the complaint trend.

• Brand Name: FACIAL ID-ORTHOG-4PLATES
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG - MHRA ORG ID:31814; 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: jade barrioga ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 19084362
• Report Number: 0008010177-2024-00028
• Device Sequence Number: 8283415
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 07/25/2024

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: 78-92004
• Device Lot Number: 2311281002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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