BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR (40 DEG FWD), 4MM

    MDR report key: 1067562 · Received June 26, 2008

    Report

    Report Number
    1649384-2008-00338
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED DURING CLEANING. NO PATIENT CONTACT. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUEST HAD BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MFR DATE IS UNKNOWN. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 29 MAY 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING CLEANING, IT WAS IDENTIFIED THAT THE SCREW HAD FALLEN OUT OF THE RONGEUR. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR (40 DEG FWD), 4MM HARMONY HTX ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1