BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER SINGLE-INNER SETSCREW

    MDR report key: 1822459 · Received August 26, 2010

    Report

    Report Number
    1526439-2010-00125
    Event Type
    Injury
    Date Received
    August 26, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING WAS RETURNED FOR EVAL. PT WAS REPORTED TO BE OBESE AND ALSO TO HAVE FALLEN SOME TIME AFTER SURGERY. PT WEIGHT AS WELL AS POST-OP TRAUMA MAY HAVE CONTRIBUTED TO THIS ADVERSE OUTCOME. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. IT ALSO LISTS PT WEIGHT AS A CONSIDERATION IN THE PT SELECTION CRITERIA, AS OBESE PATIENTS CAN PRODUCE GREATER LOAD ON THE IMPLANTS.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT SURGEON INFORMED HIM THAT A PT IMPLANTED WITH VIPER SPINAL HARDWARE EXPERIENCED POST-OP CONSTRUCT LOOSENING. PT IS REPORTED TO BE OBESE AND HAVE SUFFERED A FALL SOMETIME AFTER SURGERY. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION, AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER SINGLE-INNER SETSCREW SPINAL FIXATION DEVICE MNI DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RODS| PEDICLE SCREWS