BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFIX

    MDR report key: 855689 · Received May 25, 2007

    Report

    Report Number
    1649384-2007-00053
    Event Type
    Injury
    Date Received
    May 25, 2007
    Date of Event
    January 9, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Removal / Correction Number
    CR#1649384-4/6/2005-001-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS PERFORMED BY REVIEWING THE DEVICE HISTORY RECORD, INSPECTING THE RETURNED PRODUCT, AND REVIEWING THE INFIX TRAINING LOG AND SURGICAL TECHNIQUE. THE INVESTIGATION DETERMINED THE DAMAGE TO THE DISTRACTOR WAS DUE TO USE ERROR. THE RUBBER MALLET WAS USED WHEN INITIALLY INSERTING THE STRUTS INSTEAD OF FINGER PRESSURE PER THE SURGICAL TECHNIQUE. THIS EVENT IS ASSOCIATED WITH CR# 1649384-4/6/2005-001-C THAT PROVIDED SUPPLEMENTAL TRAINING FOR SALES REPRESENTATIVES AND SURGEONS PRIOR TO SHIPMENT OF PRODUCT FOR IMPLANTATION. THE SURGEON ASSOCIATED WITH THE EVENT WAS TRAINED IN 2005. FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IN 2007, DURING AN INFIX CASE, AFTER THE ENDPLATES WERE IMPLANTED, THE STRUTS WERE INSERTED USING THE MALLET. THE STRUTS DISLODGED FROM THE DISTRACTOR DURING INSERTION. THE SURGEON REMOVED THE ENDPLATES AND UPON INSPECTION NOTED THAT THE ENDPLATES AND THE DISTRACTOR WERE DAMAGED. THE CASE WAS COMPLETED WITH ANOTHER IMPLANT WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFIX DISTRACTOR, MEDIUM KWQ ABBOTT SPINE, INC. NA 17XX

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 1801 ENDPLATE