BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF TAP 4MM WIDERT SCREW INTTHRD 15

    MDR report key: 1023415 · Received April 2, 2008

    Report

    Report Number
    1649384-2008-00194
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PROD. REQUEST HAS BEEN MADE TO OBTAIN THE PROD. EVAL IS PENDING UPON THE RETURN OF THE PROD.

    Description of Event or Problem · 1

    IN 2008 THE SALES REPORTED THAT DURING A CERVICAL PROCEDURE THE SURGEON WAS IMPLANTING A PLATE, AND HAD ALREADY IMPLANTED 2 SCREWS WHEN HE DETERMINED THAT IT WAS THE WRONG SIZE PLATE. THE SURGEON THEN ATTEMPTED TO EXPLANT THE SCREWS AND PLATE, AND THE SURGEON WAS NOT ABLE TO BACK OUT THE SECOND SCREW AND BROKE THE VERTEBRAL BODY IN ORDER TO REMOVE THE PLATE AND SCREW. THE SURGEON DID A CORPECTOMY AND IMPLANTED ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF TAP 4MM WIDERT SCREW INTTHRD 15 ACUFIX KWQ ABBOTT SPINE, INC. 45ZY

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention