BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 1665060 · Received April 20, 2010

    Report

    Report Number
    3005039508-2010-00009
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Removal / Correction Number
    30050395808-01/29/2010-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    30050395808-01/29/2010-001-R.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE SURGEON USED THE MINI MAXTORQUE SET THIS MORNING FOR THE FIRST TIME AND THE HEX DRIVER TIP BROKE IN THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGN HCS-056-38 1067061

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention