BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRLOCK VOLAR PLATE SYSTEM

    MDR report key: 787843 · Received November 17, 2006

    Report

    Report Number
    3005039508-2006-00002
    Event Type
    Malfunction
    Date Received
    November 17, 2006
    Date of Event
    July 12, 2006
    Report Date
    November 17, 2006
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOCKING SCREW DID NOT ENGAGE WITH THE PLATE AND PASSED THROUGH THE PLATE HOLE. SURGEON REMOVED THE SCREW AND REPLACED IT WITH ONE THAT DID ENGAGE WITH THE PLATE. SURGEON REPORTED BY LETTER THAT THERE WAS NO ADVERSE HEALTH EFFECT AND THAT IT TOOK LESS THAN TWO MINUTES TO REPLACE THE AFFECTED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRLOCK VOLAR PLATE SYSTEM ORTHOPEDC IMPLANT HRS ORTHOHELIX SURGICAL DESIGNS, INC. * S200

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other