BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROC

    MDR report key: 1032281 · Received April 21, 2008

    Report

    Report Number
    2027467-2008-00008
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 7, 2008
    Report Date
    February 26, 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

    THERE WERE TWO PART NUMBERS INVOLVED ON THIS CASE AND THEY WERE PART NUMBERS: 81009 AND 81070-840. THE INITIAL REPORTER DID NOT PROVIDE THE LOT NUMBER FOR THE ROC NUT PART NUMBER 81009. THE BOLTS PART NUMBER 81070-840 LOT NUMBER 616185D WERE MANUFACTURED ON 02/07/2008 WITH LOT SIZE OF 89. THE DEVICE HISTORY RECORD AND QUALITY INSPECTION REPORT FOR LOT 616185D WERE EVALUATED AND DO NOT REVEAL ANY QUALITY CONCERNS. THE PARTS WERE UNAVAILABLE FOR EVALUATION. THE ROC INSTRUCTIONS FOR USE SECTION INTRAOPERATIVE MANAGEMENT INDICATES THE IMPORTANCE OF TIGHTENING NUTS TO TORQUE VALUES.

    Description of Event or Problem · 1

    THE THREADS OF A ROC NUT BINDED UP WITH THE THREADS OF A BOLT. THE ROC NUT COULD NOT TIGHTEN DOWN ONTO THE PLATE. THERE IS A SMALL GAP BETWEEN THE ROC NUT AND THE PLATE. THE IMPLANTS REMAIN INSIDE THE PATIENT. THERE IS NO PLAN FOR A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROC ROC LUMBAR PLATING SYSTEM MNI ALPHATEC SPINE, INC. 81009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1