MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE; IMPLANT

Model Number	55-15911
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 was discovered fractured post operative.There was a revision surgery to remove the plate.
Additional Manufacturer Narrative
The reported event could be confirmed as the reported plate was returned for investigation.The plate was secured with the adequate screws of the module and all fragments could be removed from the patient according to the sales rep.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 probable cause was ¿insufficient bone quality¿ due to the tumor.This would lead to lack of fixation and chronic stress on the plate leading to plate fracture.In sum, the root cause of the breakage might have been one or multiple powerful dynamic overloads of the fracture area.
Event or Problem Description
It was reported that the plate was discovered fractured post operative.There was a revision surgery to remove the plate.

• Brand Name: PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE
• 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: 17164853
• Report Number: 0008010177-2023-00042
• Device Sequence Number: 14892255
• Product Code: JEY
• UDI-Device Identifier: 04546540356376
• UDI-Public: 04546540356376
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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: 55-15911
• Device Catalogue Number: 55-15911
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/20/2023
• 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: Required Intervention
• Patient Sex: Unknown