BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATHFINDER

    MDR report key: 1143634 · Received August 28, 2008

    Report

    Report Number
    1649384-2008-00444
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. NOTE: A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OF INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT TO FDA THAT THE REPORT OF INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, OR ITS EMPLOYEES OR AGENTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND MAY EXPRESSLY RESERVE THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT OR EMPLOYEES THEREOF CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED ON AN UNKNOWN DATE THE PT WAS COMPLAINING OF PAIN. X-RAYS WERE DONE AND THE RESULTS SHOWED TWO BROKEN SCREWS. THE PT UNDERWENT A REVISION SURGERY ON THE SAME DAY TO EXPLANT THE BROKEN SCREWS. THE TOP PORTIONS OF BOTH SCREWS WERE REMOVED. THE PT WAS REINSTRUMENTED WITH ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER PATHFINDER KWP ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention POLYAXIAL PEDICLE SCREW