BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC SPINE SCREW

    MDR report key: 13798260 · Received March 16, 2022

    Report

    Report Number
    MW5108212
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 14, 2022
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALPHATEC PIECE OF SPINE SCREW SHEARED OFF IN BONE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525838 ALPHATEC SPINE SCREW APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP ALPHATEC SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male