BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROC

    MDR report key: 1111936 · Received August 11, 2008

    Report

    Report Number
    2027467-2008-00012
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 11, 2008
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K050078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN SCREW WAS RETURNED WITH THE NUT ATTACHED TO ONE PART OF THE SCREW. THE SCREW WAS CONFIRMED TO BE BROKEN. THE MANUFACTURE DATE OF PART NUMBER 81070-340 LOT NUMBER 605555C WAS ON 02/14/06. THE DEVICE HISTORY FOR LOT #: 605555C WAS EVALUATED AND DO NOT REVEAL ANY QUALITY CONCERNS. THE INITIAL REPORTER CONFIRMED THAT THE BROKEN PLATE FOUND DURING THE REVISION SURGERY WAS MADE BY A DIFFERENT MANUFACTURER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP OF THE BROKEN PLATE TO THE BROKEN SCREW. THE ROC LUMBAR PLATING SYSTEM INSTRUCTIONS FOR USE STATE: CONTRAINDICATIONS: THE ROC LUMBAR PLATING SYSTEM IS CONTRAINDICATED FOR: USE WITH STAINLESS STEEL COMPONENTS OR COMPONENTS FROM OTHER SYSTEMS. THE IMPLANT WAS INSIDE THE PATIENT FOR APPROXIMATELY 25 MONTHS. THE NATURE OF THE BROKEN SCREW WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    A ROC PEDICLE SCREW AND A PLATE WERE DISCOVERED TO BE BROKEN DURING A SCHEDULED REVISION SURGERY. THE DATE OF THE SCREW BREAKAGE IS UNKNOWN. THE SCREW WAS REMOVED AND REPLACED. THE BROKEN PLATE WAS MANUFACTURED BY A DIFFERENT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROC ROC LUMBAR PLATING SYSTEM MNI ALPHATEC SPINE, INC. 81070-340 605555C

    Patients

    Seq Age Sex Outcome Treatment
    1