BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER II OPEN SCREW EXTENSION

    MDR report key: 1230731 · Received October 24, 2008

    Report

    Report Number
    1526439-2008-00174
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 24, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. OUR SALES REP PERFORMED AN EVALUATION OF THE INSTRUMENT SET AND REPORTED FINDING ONE DEVICE BENT FROM APPLIED FORCE, BUT THERE WAS NO DIFFICULTY DURING SIMULATED USE TESTING OF MATING PARTS. THE SET WAS USED AGAIN WITHOUT ISSUE.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT DIFFICULTY USING SEVERAL OF THE INSTRUMENTS THAT ARE PART OF THE VIPER FAMILY OF SURGICAL IMPLANTS. THESE DIFFICULTIES COMBINED TO RESULTED IN AN EXTENSION OF SURGERY IN EXCESS OF 30-MIN. THE ISSUE RESULTED IN SOME FRUSTRATION FOR THE USER, BUT DID NOT CAUSE ANY PT INJURY. AS THE DELAY WAS IN EXCESS OF 30-MIN, MDR IS BEING FILED TO DOCUMENT THIS EVENT. DEVICE 1 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER II OPEN SCREW EXTENSION MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK