BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 3-D HEAD FOR TI CLICK 'X SCREWS

    MDR report key: 2010677 · Received February 25, 2011

    Report

    Report Number
    1719045-2011-00059
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    December 17, 2010
    Report Date
    February 2, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNH
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CLICK 'X SEVERAL YEARS AGO. ONE ROD SLID OUT OF THE SCREW. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF LOCKING CAP AND SCREW AND REVISION TO VAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI 3-D HEAD FOR TI CLICK 'X SCREWS NONE MNH SYNTHES (USA) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING CAPS| 3-D HEADS| RODS| SCREWS