BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATARJET

    MDR report key: 5100481 · Received September 24, 2015

    Report

    Report Number
    5100481
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 16, 2015
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEPUY MITEK SCREW: AT THE LAST OFFICE VISIT THE PATIENT WAS SEEN WITH A 6-MONTH HISTORY OF RIGHT SHOULDER PAIN. THE PAIN WAS INITIATED BY INJURY AFTER A SEIZURE. THE PATIENT DESCRIBES THE PAIN AS CONSTANT, DULL AND ACHY THAT OCCURS WITH ACTIVITY AND AT NIGHT. THE SHOULDER PAIN IS LOCATED IN THE GLENOHUMERAL REGION AND DOES NOT RADIATE DOWN THE ARM. THE PAIN IS INCREASED WITH ACTIVITY. THE PATIENT STATES HAVING A 'GRINDING' SENSATION IN THE SHOULDER WITH GLENOHUMERAL JOINT MOTION. X-RAYS WERE OBTAINED IN THE EMERGENCY DEPARTMENT (ED) WITH EVIDENCE OF BROKEN HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630256 LATARJET SCREW, FIXATION, BONE HWC DEPUY MITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R OTHER, AT THE LAST OFFICE VISIT THEY WERE SEEN W