BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2045583 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00031
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    July 27, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K062391
    Removal / Correction Number
    2032499-012511-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: (B)(4) PULL PINS WERE MANUFACTURED SMALLER THAN THE DIMENSIONAL REQUIREMENTS, CAUSING THEM TO THREAD INTO (B)(4) SCREWS WITH MINIMAL LOCKING FORCE. THE SUPPLIER PRODUCED THE (B)(4) PULL PINS USING HIS OWN NOMINAL TARGETS WITHOUT REGARD FOR TOLERANCES BASED ON THE SPECIFIED THREAD STANDARD. AS A CORRECTIVE ACTION, THE PULL PIN SUPPLY WAS REMOVED FROM THE ORIGINAL MANUFACTURER AND MOVED TO THE SAME VENDOR WHO MADE THE SCREWS. IN ADDITION, ALL THREAD CALLOUTS ARE SUPPLEMENTED WITH SPECIFIC DIMENSIONAL TOLERANCES. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE PULL PIN WAS LOOSE BEFORE THE COMPRESSION AND THE PULL PIN CAME OFF DURING SURGERY. THE SURGEON SCREWED IN THE IMPLANT TOO FAR INITIALLY; UPON COMPRESSION, THERE WAS NO RESISTANCE. DURING THE CASE, THE SURGEON TOOK THE PULL PINS OFF AND USED THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MRW INTERVENTIONAL SPINE, INC. 9045-02 050709-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention