BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGUAR LUMBAR I/F CAGE 9X9X25MM

    MDR report key: 1587680 · Received January 20, 2010

    Report

    Report Number
    1526439-2010-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    January 19, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    P960025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAGE WAS LEFT IMPLANTED AND THE BROKEN FRAGMENT NOT RETURNED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS ATYPICAL FORCE PLACED ON THE CAGE DURING INSERTION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AND THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE WARNS AGAINST THE USE OF ATYPICAL FORCE.

    Description of Event or Problem · 1

    A PORTION OF THE CARBON FIBER IMPLANT WAS BROKEN OFF DURING INSERTION. THIS OCCURRED AFTER THE DOCTOR TRIED TO MOVE THE CAGE BETWEEN L4 AND L5 WITH THE INSERTION INSTRUMENT. THE PIECE WAS REMOVED FROM THE PATIENT AND THE CAGE LEFT IN PLACE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AS A COMPROMISED IMPLANT WAS LEFT IN VIVO AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGUAR LUMBAR I/F CAGE 9X9X25MM VBA IMPLANT MAX DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK