BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR- 40 DEGREE FWD-3MM

    MDR report key: 1031307 · Received April 18, 2008

    Report

    Report Number
    1649384-2008-00214
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING SURGERY THE SURGEON HAD THE INSTRUMENT DOWN IN THE PORT WHEN THE SCREW FELL OUT OF THE HANDLE AND FELL ONTO THE FLOOR. THERE WAS NO REPORT OF PT INJURY OR SURGICAL DELAY. THE MALFUNCTION AS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR- 40 DEGREE FWD-3MM HARMONY HTX ABBOTT SPINE, INC. 38BZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK