MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 2MM BAR, LEFT, STANDARD, 5 HOLE, MIDFACE; IMPLANT

Model Number	55-06760
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
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 that the plate broke post-operative and the patient underwent a second surgery to remove/replace the plate.
Event or Problem Description
It was reported that the plate broke post-operative and the patient underwent a second surgery to remove/replace the plate.
Additional Manufacturer Narrative
Update: d9,h3.The investigation results show that the postoperative plate fractures occurred through a bar and through a fixation hole, so the reported event could be confirmed.Based on the performed investigation, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.

• Brand Name: L-PLATE, 100 DEGREE, 2MM BAR, LEFT, STANDARD, 5 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: 16098642
• Report Number: 0008010177-2023-00001
• Device Sequence Number: 17805304
• Product Code: JEY
• UDI-Device Identifier: 04546540365996
• UDI-Public: 04546540365996
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/23/2023

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
• Device Model Number: 55-06760
• Device Catalogue Number: 55-06760
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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 Age: 26 YR
• Patient Sex: Male