BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE VBR 9X7X27MM

    MDR report key: 1170747 · Received September 15, 2008

    Report

    Report Number
    1526439-2008-00165
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 11, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K052746
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REP DISCUSSED THE PROBLEM WITH THE SURGEON AFTER THE CASE. SURGEON THOUGHT THAT THE CAGE MAY HAVE BEEN LOOSE UPON THE INSERTER OR IMPROPERLY ATTACHED THE HANDLE. IF THE IMPLANT WAS NOT FULLY SEATED ON THE INSERTER IT COULD RESULT IN DAMAGE TO THE IMPLANT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE 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 EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAGE WAS DAMAGED DURING INSERTION. THE SURGEON NOTICED CAGE WAS PLACED SLIGHTLY ANTERIOR TO WHERE HE WOULD HAVE PREFERRED IT. HE ATTEMPTED TO REINSERT THE HANDLE TO THE CAGE IN ORDER TO PULL IT BACK, BUT COULD NOT LOCATE THE INSERTION HOLE. HE DID NOTICE A SMALL PIECE OF FOREIGN MATERIAL THAT HE THOUGHT MIGHT HAVE BEEN A PART OF THE CAGE. IT WAS REMOVED AND DISCARDED. CAGE WAS LEFT AS IS AND LOCKED DOWN WITH PEDICLE SCREWS. USER REPORTED NO ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS SITUATION. AS A COMPROMISED IMPLANT WAS LEFT IN THE BODY AN MDR WAS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCORDE VBR 9X7X27MM VBR IMPLANT MQP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK