BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER MIS CANNULATED SCREW 6X40MM, TI

    MDR report key: 1870807 · Received October 11, 2010

    Report

    Report Number
    1526439-2010-00147
    Event Type
    Injury
    Date Received
    October 11, 2010
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K071860
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT FULLY TIGHTENED AND ASSEMBLED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTED POST-OP LOOSENING OF VIPER HARDWARE SYSTEM. ON (B)(6) 2010, INSTRUMENTATION WAS DONE FOR L1 TO L3 SPINAL FUSION WITH VIPER SYSTEM. AT SOME POINT AFTER THE SURGERY, IT WAS FOUND THAT THE SCREW USED FOR L1 WAS LOOSENED. THE PT IS UNDER OBSERVATION AND THE SURGEON HAS TAKEN NO ACTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER MIS CANNULATED SCREW 6X40MM, TI SPINAL FIXATION DEVICE NKB DEPUY SPINE INC. NA ALJBTB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention