MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FRACTURE PLATE, C-SHAPE,4-HOLES, WITH ARROW; IMPLANT

Model Number	92-55524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device implanted in patient.
Event or Problem Description
It was reported that a patient had mandible plates break while eating.Scan for revision surgery planned.
Additional Manufacturer Narrative
Based on the follow up information provided by the stryker sales rep, the 92-55524 plate was bent but did not meet the needs/desires as a fixation option for this patient fx and anatomy.It had nothing to do with the 55-15536 plate.The 92-55524 plate is captured under pr mdr 2908801.The reported device did not cause or contribute to the event.
Event or Problem Description
It was reported that a patient had mandible plates break while eating.Scan for revision surgery planned.

• Brand Name: FRACTURE PLATE, C-SHAPE,4-HOLES, WITH ARROW
• 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: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13228006
• Report Number: 0008010177-2022-00002
• Device Sequence Number: 11803252
• Product Code: JEY
• UDI-Device Identifier: 07613154546527
• UDI-Public: 07613154546527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K014263
• 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): 03/28/2022

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: Other
• Device Model Number: 92-55524
• Device Catalogue Number: 92-55524
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/28/2022
• 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