BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE-LOK PLS IMPLANT

    MDR report key: 2045654 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00005
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    June 22, 2009
    Report Date
    July 2, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K043351
    Removal / Correction Number
    2032499-0112511-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PULL PIN IS A COMPONENT THAT IS THREADED INTO THE FACET SCREW. AFTER THREADING THE SCREW INTO THE BONE, THE PULL PIN IS GRABBED WITH AN INSTRUMENT KNOWN AS A COMPRESSION TOOL; THE PULL PIN IS HELD WHILE THE INSTRUMENT COMPRESSED THE SCREW HEAD AGAINST THE BONE, ACHIEVING A LOCKED POSITION. THE PULL PIN IS THEN UNTHREADED AND REMOVED FROM THE SCREW. AFTER COMPRESSING THE SCREW, THE PULL PIN PREMATURELY DISENGAGED. THE SURGEON THEN USED ANOTHER TOOL TO FURTHER SCREW THE IMPLANT, FULLY SEATING IT. THE PROCEDURE WAS THEN COMPLETED WITH NO ADVERSE IMPACT ON THE PT. THE INVESTIGATION REVEALED THAT THE PULL PIN SUPPLIER MFG THE THREAD ON THE PULL PIN .003" SMALLER THAN THE LOWER SPECIFICATION LIMIT. THE SCREW, SUPPLIED BY ANOTHER VENDOR, MFG THE MATING SCREW THREADS AT NOMINAL. WITH THE PULL PIN SMALLER THAN REQUIRED, THE LOCKING MECHANISM WAS COMPROMISED. THE PULL PIN SUPPLIER HAS NOW BEEN CHANGED AND THE CURRENT SUPPLIER NOW MFRS BOTH THE PULL PIN AND THE MATING SCREW.

    Description of Event or Problem · 1

    AFTER IMPLANTING A FACET SCREW, A SUBCOMPONENT, KNOWN AS THE PULL PIN, WAS PREMATURELY DISENGAGED. THE SCREW WAS NOT FULLY COMPRESSED, SO THE SURGEON USED ANOTHER INSTRUMENT, KNOWN AS THE DRIVER, TO FULLY SEAT THE IMPLANT AGAINST THE BONE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE AFFECT TO THE PT. THE SURGEON IMPLANTED 6 SCREWS IN TOTAL; 2 OF THE 6 SCREWS HAD PULL PINS THAT PREMATURELY DISENGAGED DURING COMPRESSION OF THE IMPLANT. IT SHOULD BE NOTED THAT ON (B)(6) 2009, THE COMPLAINT WAS EVALUATED FOR POSSIBLE REPORTING, AND THE DECISION NOT TO REPORT WAS MADE. UPON RE-REVIEW, IT WAS DECIDED THAT THIS EVENT SHOULD BE REPORTED. IT SHOULD ALSO BE NOTED THAT THIS COMPLAINT IS SIMILAR IN NATURE TO 2032499-2011-0001 AND 2032499-2011-00002.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention