BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER MIS CANNULATED POLYAXIAL SCREW 6X45MM

    MDR report key: 2153142 · Received June 17, 2011

    Report

    Report Number
    1526439-2011-00104
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE DEVICE FOR EVAL. A F/U MEDWATCH REPORT WILL BE SUBMITTED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    CONTACT REPORTS THE HEAD OF THE POLYAXIAL SCREW BROKE WHEN INSERTING A ROD DURING A MINIMALLY INVASIVE PROCEDURE. AS A RESULT, THE PROCEDURE WAS CHANGED FROM MINIMALLY INVASIVE TO AN OPEN PROCEDURE. A SMALL OPENING WAS MADE LARGER TO INSERT THE ROD AND IT APPEARED THAT THE SCREW HEAD WAS SITTING ON THE THREADS OF THE SHANK. THE DIFFICULTY RESULTED IN A DELAY OF 150 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER MIS CANNULATED POLYAXIAL SCREW 6X45MM SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA AMFCMR

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR