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

Model Number	55-07764
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plates were discovered to be 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.
Event or Problem Description
It was reported that the plates were discovered to be broken and a revision surgery was performed.
Additional Manufacturer Narrative
Update: h6 the reported event could be confirmed: the returned plate shows a fracture.The macroscopic appearances of the plate point to exceeding the material strength.That is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structure and the secondary crack in the area of the breakages.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 stated that to his opinion the plate was installed properly.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.

• Brand Name: L-PLATE, 100 DEGREE, 8MM BAR, LEFT, 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: 17129993
• Report Number: 0008010177-2023-00034
• Device Sequence Number: 15300755
• Product Code: JEY
• UDI-Device Identifier: 04546540366139
• UDI-Public: 04546540366139
• 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: 55-07764
• Device Catalogue Number: 55-07764
• Device Lot Number: UNKNOWN
• 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: 06/14/2023
• 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