BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVEL VBR SPINAL SYSTEM

    MDR report key: 836315 · Received April 3, 2007

    Report

    Report Number
    2027467-2007-00005
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    March 5, 2007
    Report Date
    April 3, 2007
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    k050553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE PRODUCTION RECORD DID NOT RETURN ANY QUALITY CONCERNS. A VISUAL EXAMINATION OF THE DEVICE CONFIRMS THA STRIPPED THREADS OF THE CAGE. A ROOT CAUSE CANNOT BE IDENTIFIED. IT IS UNK IF THREADS OF THE CAGE WERE STRIPPED BEFORE THE SURGERY AND AFTER MANIPULATION BY THE SURGEON.

    Description of Event or Problem · 1

    THE ACC PEEK CAGE WAS STRIPPED AND UNUSABLE IN SURGERY. THIS WAS NOTED DURING THE SURGERY. AS A RESULT OF THE STRIPPED CAGE, THE SURGERY WAS PROLONGED APPROXIMATELY 30 MINUTES. THE SURGEON DECIDED TO USE ANOTHER CAGE OF THE SAME SIZE AND PART NUMBER TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVEL VBR SPINAL SYSTEM NOVEL PEEK VBR KWQ ALPHATEC SPINE, INC. 64513-110 501162A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR