BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCS 3.5MM BONE SCREW

    MDR report key: 4853071 · Received May 12, 2015

    Report

    Report Number
    3006340236-2015-00006
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    March 25, 2015
    Report Date
    May 8, 2015
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    OVE
    PMA / PMN Number
    K142940
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TCS 3.5MM BONE SCREW WAS REVIEWED PRIOR TO RELEASE TO THE FIELD; NO ANOMALIES OR DISCREPANCIES WERE NOTED. THE DEVICE WAS FOUND TO BE CONFORMING TO THE SPEC.

    Description of Event or Problem · 1

    DURING A C6-7 PROCEDURE, WHILE THE SURGEON WAS SEATING THE SCREWS INTO THE BONE, THE EXOSKELETON TCS 6 DEGREE LORDOTIC MEDIUM IMPLANT WAS PULLED POSTERIORLY. THE SURGEON REVISED THE PLACEMENT OF THE IMPLANT IN THE DISK SPACE BY REMOVING THE SCREWS AND USING AN ANTERIOR PLATE. UPON REMOVAL OF THE SCREWS, THE LOCK-RING OF ONE OF THE SCREWS HAD FALLEN OFF AND WAS FOUND WITHIN THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310175 TCS 3.5MM BONE SCREW BONE SCREW, OVE/ODP OVE TITAN SPINE, LLC NA V01

    Patients

    Seq Age Sex Outcome Treatment
    1