BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDEWIRE 1.6MM X 500MM

    MDR report key: 1122752 · Received August 18, 2008

    Report

    Report Number
    3005977257-2008-00001
    Event Type
    Injury
    Date Received
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROMPT INVESTIGATION WAS INITIATED TO OBTAIN RELEVANT INFO RELATING TO THE EVENT. LIMITED INFO PROVIDED TO DATE. DEVICE HAS NOT BEEN RETURNED FOR EVAL. LOT NUMBER IS UNK AT THIS TIME. INVESTIGATION REMAINS ON-GOING. F/U REPORT WILL BE FILED AS ADD'L RELEVANT INFO IS OBTAINED.

    Description of Event or Problem · 1

    A PT WITH A PREVIOUSLY IMPLANTED FACET FUSION PRESENTED WITH A BROKEN FACET JOINT FOLLOWING A FALL. DURING EXAMINATION, A PREVIOUSLY UNRETRIEVED FRAGMENT OF A K-WIRE WAS FOUND TO HAVE MIGRATED FROM THE VERTEBRAE. IT IS NOT KNOWN WHAT CAUSED THE MIGRATION. THE ORIGINAL PROCEDURE RESULTING IN THE UNRETRIEVED FRAGMENT HAD NOT BEEN REPORTED. REVIEW OF CT SCAN AND CONSULT WITH GENERAL SURGEON CONDUCTED AND DETERMINED THAT INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED GUIDEWIRE 1.6MM X 500MM HXI SPINEFRONTIER, INC. SI00060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other