BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2045584 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00032
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    July 20, 2009
    Report Date
    August 18, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K043351
    Removal / Correction Number
    2032499-012511-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: 2081-00 PULL PINS WERE MANUFACTURED SMALLER THAN THE DIMENSIONAL REQUIREMENTS, CAUSING THEM TO THREAD INTO 2080-01 SCREWS WITH MINIMAL LOCKING FORCE. THE SUPPLIER PRODUCED THE 2081-00 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

    SURGEON IMPLANTED TWO PERPOS SCREWS IN TOTAL. WHEN COMPRESSING MODEL 9024-00, THE SURGEON ATTEMPTED TO COMPRESS USING THE COMPRESSION TOOL. ONE OF THE PULL PINS DISENGAGED FROM THE HEADING DURING COMPRESSION. AS SCREW WAS NOT FULLY COMPRESSED, THE SCREWDRIVER WAS PLACED ONTO HEAD OF SCREW AND SCREWED TIGHT. THE OTHER SCREW WAS FROM LOT 052708-A AND IT FULLY COMPRESSED. PT WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MRW INTERVENTIONAL SPINE, INC. 9024-00 050709-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention