BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZODIAC PEDICLE SCREW SYSTEM

    MDR report key: 1012857 · Received March 12, 2008

    Report

    Report Number
    2027467-2008-00005
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K033090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE HISTORY RECORD REVEALS THAT THE INSTRUMENT IS A CUSTOMIZED DEVICE. THE INSTRUMENT IS A THINNER VERSION STRAIGHT BONE PROBE. CUSTOMIZED INSTRUMENTS ARE NOT MARKETED BY ALPHATEC SPINE AND ARE NOT GENERALLY AVAILABLE TO CUSTOMERS THROUGH COMMERCIAL DISTRIBUTION. EACH CUSTOMIZED DEVICE REQUIRES A CUSTOM REQUEST FORM FROM THE SURGEON. AN EVALUATION OF THE RETURNED PART CONFIRMS THE COMPLAINT. THE TIP OF THE INSTRUMENT BROKEN OFF. THE TIP APPEARS TO BE TWISTED. THE DESIGN ENGINEER CONCLUDED THAT THE SHAFT OF THE INSTRUMENT WAS STUCK INSIDE A PEDICLE CAVITY. THE SURGEON ATTEMPTED TO INSERT THE PROBE INTO A HOLE THAT WAS TOO SMALL. THE SURGEON ATTEMPTED TO REMOVE THE INSTRUMENT BY TWISTING IT. THE TWISTING FORCE CAUSED THE TIP OF THE PROBE TO BREAK OFF INTO THE PT. ALPHATEC SPINE IS UNAWARE OF THE SPECIFIC INTENDED USE OF THE INSTRUMENT. THE NUMBER OF USES OF THE DEVICE BY THE SURGEON IS UNK.

    Description of Event or Problem · 1

    THE TIP OF THE THINNER PEDICLE PROBE BROKE OFF INTO THE PT'S BODY AT L4 DURING SURGERY. THE SURGEON REMOVED THE BROKEN TIP FROM THE PT AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZODIAC PEDICLE SCREW SYSTEM ZODIAC POLYAXIAL SCREW SYSTEM MNI ALPHATEC SPINE, INC. C62904-C11 C-1938

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR