BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-MESH VBR CAGE 0-DEGREE 28-38MM

    MDR report key: 1844786 · Received September 23, 2010

    Report

    Report Number
    1526439-2010-00136
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K080568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAGE WAS RETURNED WITH THE SETSCREW JAMMED IN THE OPEN POSITION. THE CAGE MOVES FREELY WITHOUT ISSUE. SIGNIFICANT FORCE WAS APPLIED BUT THE SETSCREW REMAINED FROZEN IN PLACE. NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. THE SETSCREW IS CHECKED TO ENSURE THAT IT IS PROPERLY RETAINED AND FREE MOVING PRIOR TO PACKAGING. IT CANNOT BE DETERMINED IF THE SETSCREW MAY HAVE BEEN JAMMED DURING DEMONSTRATION PRIOR TO THE CASE OR AT POINT OF USE.

    Description of Event or Problem · 1

    AFTER PLACING THE X-MESH CAGE AND TAKING A/P SHOT SURGEON ATTEMPTED TO DISENGAGE THE INSERTER, HE WAS UNABLE TO ENGAGE THE SETSCREW. AFTER MULTIPLE ATTEMPTS HE TRIED TO BACK OFF THE TENSION ON THE INSERTER IN HOPE OF LINING UP THE SETSCREW. THIS ALSO DID NOT WORK AND THEY ATTACHED THE POSTERIOR X-MESH INSERTER. HE WAS THEN ABLE TO RE-EXPAND THE CAGE AND ENGAGE THE SETSCREW. HE THEN NOTED THAT A PORTION OF A DRIVER HAD BEEN BROKEN IN THE SETSCREW. THE PIECE WAS REMOVED WITH BONE WAX. AFTER REPOSITIONING THE CAGE AND BELIEVING HE HAD LOCKED THE CAGE IN PLACE. HE REMOVED THE INSERTER AND THE CAGE COLLAPSED. HE REMOVED THE ANTERIOR CAGE AND PLACED A POSTERIOR CAGE TO COMPLETE THE CASE. THERE WAS NO ADVERSE PT INJURY AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-MESH VBR CAGE 0-DEGREE 28-38MM VBR IMPLANT MQP DEPUY SPINE, INC. NA BDCG3TK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK