BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLA ROD

    MDR report key: 2003620 · Received February 23, 2011

    Report

    Report Number
    1526439-2011-00021
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 14, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN HOW MANY RODS HAVE BROKEN. DEPUY SPINE HAS REQUESTED CLARIFICATION REGARDING THE EVENT AS WELL AS RETURN OF THE AFFECTED DEVICE(S) FOR EVALUATION. A F/U REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION OR IF IT IS DETERMINED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS, THE PT WAS FIRST IMPLANTED IN 2005, TO TREAT RECONSTRUCTION OF DEGENERATIVE RACHIS DISCOPATHY. REVISION SURGERY WAS PERFORMED DUE TO BROKEN RODS. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING CATALOG NUMBER, LOT NUMBER, OR QUANTITY OF RODS THAT ARE REPORTED TO HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLA ROD SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention