BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER

    MDR report key: 1012738 · Received March 12, 2008

    Report

    Report Number
    1649384-2008-00096
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MFR DATE IS UNK. EVAL IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING A DEMONSTRATION, IT WAS NOTICED THAT THE DRIVER WOULD NOT ENGAGE THE SCREW. THERE WAS NO REPORT OF PT CONTACT. THIS MALFUNCTION AS RESULTED IS AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER CANNULATED POLYAXIAL SCREWDRIVER II-MODULAR HXX ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1