BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 889519 · Received February 23, 2007

    Report

    Report Number
    2246640-2007-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    January 25, 2007
    Report Date
    January 25, 2007
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    PMA / PMN Number
    K051781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SURGEON USED NORMAL TECHNIQUE TO PREPARE IMPLANT SPACE. PROVIDED TRIALS WERE USED TO SIZE THE SPACE. DISTRACTION WAS USED. SURGEON HAD DEVICE APPROXIMATELY 2/3 INSERTED, USING SMALL MALLET TO IMPACT, WHEN THE DEVICE BROKE. ALL PIECES WERE REMOVED, DELAY IN SURGERY REPORTED TO BE LESS THAN 5 MINUTES. ANOTHER DEVICE OF THE SAME SIZE WAS IMPLANTED WITHOUT INCIDENT OR INJURY TO PATIENT. IN REPORTER'S OPINION, THE DEVICE MAY HAVE BEEN IMPROPERLY THREADED ONTO THE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN53011-089

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention XPANSE-S IMPLANTED WITH DEVICE