BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 051MM (TI-6AL-4V NITINOL)

    MDR report key: 4862549 · Received June 23, 2015

    Report

    Report Number
    2027467-2015-00092
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 16, 2014
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. AN EVALUATION OF THE TRESTLE LUXE PLATE IS NOT POSSIBLE. THE IMPLANT REMAINS PROPERLY POSITIONED WITHIN THE PATIENT. THE IDENTIFYING LOT NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    DURING THE SURGERY, ONE OF THE PLATES LOCKING MECHANISMS POPPED UP AS THE SCREW WAS BEING INSERTED. THE SURGEON TOOK A SMALL TAMP AND KNOCKED IT BACK INTO PLACE AND LEFT THE PLATE IN WITH NO FURTHER COMPLICATION. THE PLATE REMAINED IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406485 ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 051MM (TI-6AL-4V NITINOL) KWQ KWQ ALPHATEC SPINE INC 71003-051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other