BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE TEARDROP CURETTE ANGLED

    MDR report key: 744990 · Received June 21, 2005

    Report

    Report Number
    9617544-2005-00043
    Event Type
    Malfunction
    Date Received
    June 21, 2005
    Date of Event
    May 25, 2005
    Report Date
    May 25, 2005
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    FZS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED "SURGEON WAS USING TEARDROP CURETTE TO PREPARE DISC SPACE FOR TLIF GRAFT. AS HE CONTINUED CLEARING DISC, THE TEARDROP PORTION OF THE INSTRUMENT BROKE OFF INTO THE DISC SPACE. IT WAS NECESSARY FOR THE SURGEON TO TAKE ADDITIONAL TIME IN ORDER TO "FISH" THE BROKEN METAL OUT OF THE PT'S DISC SPACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE TEARDROP CURETTE ANGLED INSTRUMENT FZS STRYKER SPINE BORDEAUX NA 047233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other