BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZODIAC STAINLESS STEEL SPINAL FIXATION SYSTEM

    MDR report key: 769736 · Received September 22, 2006

    Report

    Report Number
    2027467-2006-00013
    Event Type
    Other
    Date Received
    September 22, 2006
    Report Date
    September 22, 2006
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K051286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PART INVOLVED: 8.5MM X 70MM LENGTH MONOAXIAL BONE SCREW PART NUMBER 82285-70. THE OFFSET CONNECTOR IS DISENGAGED FROM THE ENTIRE CONSTRUCT AT THE ILIAC BONE JUNCTION. THE DISENGAGED PARTS REMAIN IN THE PATIENT. REGULATORY AFFAIRS WAS MADE AWARE OF INCIDENT BY SURGEON WHO PERFORMED SURGERY.

    Description of Event or Problem · 1

    THE OFFSET CONNECTOR IS DISENGAGED FROM THE ENTIRE CONSTRUCT AT THE ILIAC BONE JUNCTION. THE DISENGAGED PARTS REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZODIAC STAINLESS STEEL SPINAL FIXATION SYSTEM ZODIAC SS OFFSET CONNECTORS KWP ALPHATEC SPINE, INC. 82006-20 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR