BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE

    MDR report key: 4325060 · Received December 8, 2014

    Report

    Report Number
    MW5039489
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 14, 2014
    Manufacturer
    NUVASIVE
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON (B)(6) 2014 FOR REPORT MW5039489: NERVE HOOK USED TO REMOVE BOX TIP CURETTE FROM OPERATIVE SITE BROKE AT THE TIP. TIP WAS UNABLE TO BE REMOVED. CONFIRMED BY X-RAY.

    Description of Event or Problem · 1

    BOX CURETTE TIP BROKE OFF OF SHAFT AND HANDLE OF INSTRUMENT INSIDE PT DURING PROCEDURE. PT REPOSITIONED AND INSTRUMENT TIP REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791302 NUVASIVE BOX TIP CURETTE FZS NUVASIVE UNK
    791303 NUVASIVE NERVE HOOK LARGE, 99 DEGREE NUVASIVE NERVE HOOK KWQ NUVASIVE 6900517 119991

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR