MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 12MM BAR, RIGHT, GSP, 6 HOLE, MIDFACE; IMPLANT

Model Number	55-07767
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate was broken and a revision surgery was performed.
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.
Additional Manufacturer Narrative
The reported event could be confirmed as the plate under complaint was returned in order to determine the root cause of the failure.It was further reported that bone healing was not achieved.Related to the event in question, a review of additional documentation (x-rays) was performed.These documents and information provided were forwarded to stryker¿s senior global medical director along with the complaint information.Upon review, he also stated that to his opinion the plate was bent too much.In sum, the damages around the fractures indicate that the plate has been severely bent which decreased the material stability of the plate and led finally to the breakage.
Event or Problem Description
It was reported that the plate was broken and a revision surgery was performed.

• Brand Name: L-PLATE, 100 DEGREE, 12MM 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: 17144218
• Report Number: 0008010177-2023-00041
• Device Sequence Number: 5589722
• Product Code: JEY
• UDI-Device Identifier: 04546540366160
• UDI-Public: 04546540366160
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 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
• Device Model Number: 55-07767
• Device Catalogue Number: 55-07767
• Device Lot Number: UNKNOW
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/25/2023
• 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: Other
• Patient Sex: Unknown