BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXTORQUE ZP

    MDR report key: 1456081 · Received April 7, 2009

    Report

    Report Number
    3005039508-2009-00006
    Event Type
    Malfunction
    Date Received
    April 7, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 6, 2009
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON TRIED THE NEW SCREWS YESTERDAY AND HAD SOME SIGNIFICANT PROBLEMS AND ACTUALLY FRACTURED A METATARSAL DURING ATTEMPTED INSERTION, WHICH NEVER HAPPENED TO THE SURGEON BEFORE. THE SURGEON HAD TO SALVAGE THE CASE BY REMOVING THE SCREWS (FRACTURED BONE AROUND THE SCREWS) AND INSERT MULTIPLE K-WIRES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention