BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM SLIC SCREW DEVICE

    MDR report key: 3842710 · Received January 30, 2014

    Report

    Report Number
    3025141-2014-00006
    Event Type
    Injury
    Date Received
    January 30, 2014
    Report Date
    January 3, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K111608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SLIC SCREW BROKE POST OPERATIVELY. THE BROKEN SCREW WAS EXPLANTED AT 5 MONTHS POST OP INSTEAD OF THE RECOMMENDED 6-9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64687 25MM SLIC SCREW DEVICE SCREW, FIXATION, BONE HWC ACUMED LLC 55-0012-S 259662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention