BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 1944495 · Received December 27, 2010

    Report

    Report Number
    3005039508-2010-00022
    Event Type
    Injury
    Date Received
    December 27, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    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

    CONCLUSION: THE DRIVER TIP WAS WORN WHICH IN TURN STRIPPED THE DRIVE POCKET OF THE SCREW. THIS CONDITION THEN PREVENTED THE SURGEON FROM BEING ABLE TO COMPLETE THE SCREW IMPLANTATION.

    Description of Event or Problem · 1

    THE DRIVER STRIPPED DURING CASE. THE SURGEON DID NOT PRE-DRILL BEFORE IMPLANTING 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 1067061R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention