BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 738372 · Received June 29, 2006

    Report

    Report Number
    2246640-2006-00005
    Event Type
    Malfunction
    Date Received
    June 29, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 1, 2006
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DEVICE BREAKAGE COULD NOT BE DEFINITIVELY DETERMINED, BUT IT IS BELIEVED THAT EXCESSIVE FORCE OR LOADS APPLIED TO THE DEVICE DURING INSERTION LED TO THE BREAKAGE, WITH USER TECHNIQUE CONTRIBUTING TO THE EXCESSIVE LOADING. THE PACKAGE INSERT FOR THE DEVICE CONTAINS A WARNING THAT THE DEVICE COULD BREAK DURING INSERTION AND THAT EXCESSIVE LOADS MAY RESULT IN BREAKAGE.

    Description of Event or Problem · 1

    IMPLANT SPACE WAS PREPARED TO PROVIDE A PROPER SIZED SPACE TO INSERT THE DEVICE. THE SURGEON WAS INSERTING THE DEVICE UNTIL PROGRESSION INTO THE SPACE STOPPED. THE SURGEON THEN INCREASED THE FORCE TO MOVE THE DEVICE MORE ANTERIORLY AND SNAPPED OFF THE CORNER OF THE DEVICE. UPON X-RAY EVALUATION, THE SURGEON WAS SATISFIED WITH THE ALIGNMENT OF THE DEVICE AND THE AMOUNT OF SURFACE CONTACT. THE BROKEN PIECE WAS REPORTED TO BE APPROXIMATELY 5-10% OF THE DEVICE AND WAS READILY REMOVED, AS IT WAS STILL ATTACHED TO THE INSERTER INSTRUMENT. THIS BROKEN PIECE WAS DISCARDED BY HOSP PERSONNEL. THE REMAINING DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN53015-017

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR