BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 2151579 · Received June 29, 2011

    Report

    Report Number
    3005039508-2011-00009
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - WE CONFIRMED THE DRIVER TIP WAS BROKEN PER THE FIELD REPORT. CONCLUSION - WE CONCLUDED THAT THE FAILURE WAS METAL FATIGUE VIA TESTING OF FOUR PARTS FROM THE SAME LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE SALES REP, A DRIVER (B)(4) BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGN HCS-056-25 1067041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention