BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRLOCK VOLAR PLATE SYSTEM

    MDR report key: 787836 · Received November 17, 2006

    Report

    Report Number
    3005039508-2006-00003
    Event Type
    Malfunction
    Date Received
    November 17, 2006
    Date of Event
    August 12, 2006
    Report Date
    November 17, 2006
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOCKING SCREW DID NOT ENGAGE INTO PLATE; THEREFORE, PASSING THROUGH THE HOLE OF THE PLATE. SURGEON REMOVED THE SCREW. SURGEON REPORTED NO ADVERSE HEALTH EFFECTS AND AFFECTED SCREW WAS NOT REQUIRED FOR THE PATIENT'S SPECIFIC FRACTURE TYPE, ONLY THE BUTTRESS EFFECT OF THE PLATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other