MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 8MM BAR, RIGHT, GSP, 6 HOLE, MIDFACE; IMPLANT

Model Number	55-07765
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that upon re-operation to explant the plates due to the maxilla shifting, it was discovered that the plates were fractured.
Additional Manufacturer Narrative
The reported event (plate breakage) could not be confirmed as the plates were not returned for investigation.It has been reported that 3 plates were broken.As a result, a reoperation was performed.It was reported that the patient was compliant to post op care instructions and attended post op follow-ups regularly.The surgeon noticed movement of the maxilla in (b)(6) 2023.He also observed non-union prior to the reported plate breakages.The post op images were reviewed.The design team did not observe any broken plates (fig.1).Stryker¿s medical expert stated that non-union will cause plate breakage.Union usually occurs 4-5 months after surgery.Based on statistical evaluation, there is no indication for an incorrectly working product or any design, material or manufacturing related issue.
Event or Problem Description
It was reported by the company representative that upon re-operation to explant the plates due to the maxilla shifting, it was discovered that the plates were fractured.

• Brand Name: L-PLATE, 100 DEGREE, 8MM BAR, RIGHT, GSP, 6 HOLE, MIDFACE
• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16987428
• Report Number: 0008010177-2023-00028
• Device Sequence Number: 6853152
• Product Code: JEY
• UDI-Device Identifier: 04546540366146
• UDI-Public: 04546540366146
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/25/2023

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 Model Number: 55-07765
• Device Catalogue Number: 55-07765
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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