BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSALOCK

    MDR report key: 439102 · Received January 22, 2003

    Report

    Report Number
    439102
    Event Type
    Injury
    Date Received
    January 22, 2003
    Date of Event
    December 30, 2002
    Report Date
    January 21, 2003
    Manufacturer
    DANEK MEDICAL, INC. MEDTRONIC SOFAMORE DANEK
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILED HARDWARE. FUSION SCREWS BROKE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 4/4/03: CO HAD ALSO RECEIVED A MEDWATCH REPORT FROM THE USER FACILITY FOR THIS EVENT ON FEB 26, 2003. AFTER CONTACTING THE HOSPITAL, CO LEARNED THAT DEVICE INVOLVED IN THIS EVENT WAS NOT THE CO'S PRODUCT. CO FORWARDED THE REPORT ALONG WITH A LETTER EXPLAINING IT WAS NOT THE CO'S PRODUCT ON MARCH 13, 2003 TO THE FDA. TO WHOM IT MAY CONCERN: ON FEBRUARY 26, 2003 MEDTRONIC SOFAMOR DANEK RECEIVED A MANDATORY MEDWATCH FORM FROM HOSPITAL. INITIALLY, IT WAS NOT KNOWN IF THE PRODUCTS INVOLVED IN THE REPORT WERE MEDTRONIC SOFAMOR DANEK ITEMS DUE TO THE BRAND NAME LISTED ON THE MEDWATCH FORM. DURING A CONVERSATION ON 03/12/2003 WITH THE BIOMEDICAL COORDINATOR WITH THE HOSPITAL, IT WAS DETERMINED THAT THE ITEMS INVOLVED IN THE EVENT WERE NOT MEDTRONIC SOFAMOR DANEK ITEMS BUT WERE FROM ANOTHER MFR. IN ACCORDANCE WITH SECTION 803.22 (2), THIS LETTER, ALONG WITH THE MEDWATCH FORM FROM HOSPITAL IS BEING FORWARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALOCK FUSION SCREWS KWQ DANEK MEDICAL, INC. MEDTRONIC SOFAMORE DANEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention