BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXTORQUE ZP

    MDR report key: 1512036 · Received September 30, 2009

    Report

    Report Number
    3005039508-2009-00011
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    September 9, 2009
    Report Date
    September 9, 2009
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE THREAD DEFORMATION AND SHANK/HEAD SCORE MARKS, THE DAMAGE INDICATES HITTING ANOTHER METALLIC OBJECT ON INSERTION.

    Description of Event or Problem · 1

    WHILE DOING A LEFT BUNION PROCEDURE ON A 25 YO PT, THE SURGEON WAS REMOVING AN IMPLANTED SCREW, THE SCREW THREADS STRIPPED OFF THE SHANK OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGNS, INC. HCS-010-38-36 N793

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention