BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VBR TRIAL, 7MM

    MDR report key: 1304224 · Received January 7, 2009

    Report

    Report Number
    1526439-2009-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    December 9, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VBR TRIAL REMAINS IN THE PATIENT, AND IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED, AS THE DEVICE LOT CODE IS UNKNOWN. THE CONDITION OF THE INSERTER THAT WAS USED DURING THIS EVENT IS UNKNOWN. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE INSERTER BROKE OFF WITHIN A VBR TRIAL DURING PLACEMENT IN THE INTERSPINOUS DISC SPACE OF THE PATIENT. BECAUSE OF THE INSTRUMENT BREAKAGE, THE TRIAL COULD NOT BE REMOVED WITH ANOTHER INSERTER AND SURGEON DECISION WAS MADE TO LEAVE THE TRIAL IN THE PATIENT. COMPLETION OF THE SURGERY WAS DELAYED BY APPROXIMATELY 60 MINUTES. AS INSTRUMENT BREAKAGE OCCURRED, RESULTING THE TRIAL REMAINING IN THE PATIENT AND IN A SIGNIFICANT DELAY TO THE COMPLETION OF THE SURGICAL PROCEDURE, THIS MEDWATCH REPORT IS BEING FIELD TO DOCUMENT THIS EVENT. SEE MEDWATCH REPORT# 1526439-2009-00001 FOR THE VBR TRAIL THAT WAS ALSO INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VBR TRIAL, 7MM MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR