BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE TLX, 7MM

    MDR report key: 1759453 · Received June 24, 2010

    Report

    Report Number
    2246640-2010-00001
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 28, 2010
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    PMA / PMN Number
    K051781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT STATED TO HAVE BEEN USED TO POSITION/TURN THE IMPLANT WAS NOT APPROPRIATE FOR THE TASK AND IS LABELED AS SUCH. THE USE OF THE INSERTER TO POSITION THE IMPLANT MAY RESULT IN EXCESSIVE LOADS BEING IMPARTED TO A SMALL AREA OF THE IMPLANT, POTENTIALLY LEADING TO BREAKAGE. THERE WERE NO INDICATIONS OF NON-CONFORMITIES WITH THIS LOT OF IMPLANTS; SUBJECT IMPLANT WAS DETERMINED TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATION. AS THE INSTRUCTIONS FOR USE FOR THE DEVICE IDENTIFIES THE POSSIBILITY OF IMPLANT BREAKAGE AS A POTENTIAL ADVERSE EVENT, NO CORRECTIONS WERE DETERMINED TO BE NECESSARY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L4-L5 USING A 7MM GRAFTCAGE. BASED ON INFORMATION PROVIDED BY THE SALES AGENT PRESENT AT THE SURGERY, THE SURGEON ATTEMPTED TO TURN/POSITION THE IMPLANT USING THE INSERTER INSTRUMENT INSTEAD OF THE TAMPING INSTRUMENT, WHICH IS DESIGNED AND LABELED FOR THIS PURPOSE, AND THE CAGE REPORTEDLY BROKE INTO THREE PIECES. SURGEON WAS ABLE TO REMOVE TWO OF THE THREE PIECES, BUT IT WAS REPORTED THAT ONE PIECE (APPROXIMATELY 5MM IN SIZE) REMAINED INSIDE THE PATIENT. ANOTHER GRAFTCAGE OF THE SAME SIZE (7MM) WAS IMPLANTED WITHOUT INCIDENT OR INJURY TO THE PATIENT. AS OF (B)(6) 2010, THERE HAS BEEN NO REPORT OF ANY ADVERSE PATIENT OUTCOME. THE BROKEN IMPLANT WAS NOT RETURNED TO OSTEOTECH FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE TLX, 7MM VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention