BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA-T PLATE

    MDR report key: 2070723 · Received April 18, 2011

    Report

    Report Number
    1719045-2011-00218
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K051665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IMPLANTED AND REMOVED DURING SAME SURGERY. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION CAN BE DRAWN. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE SURGEON STARTED TO INSERT A SCREW INTO THE TI VECTRA-T PLATE 4 LEVEL AND THE SCREW WENT THROUGH THE HOLE IN THE PLATE DIS-LODGING THE PLATE HOLE CLIP. SURGEON REMOVED THE SCREW, SELECTED ANOTHER PLATE AND COMPLETED THE PROCEDURE. THERE WAS NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI VECTRA-T PLATE VECTRA PLATE KWQ SYNTHES MONUMENT NA 1604107

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR SCREW