BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTER - SMALL - 08MM

    MDR report key: 1242926 · Received November 21, 2008

    Report

    Report Number
    1649384-2008-00566
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 2, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY ON THE PREVIOUS MONTH, AN INFIX STRUT WOULD NOT ENGAGE INTO THE IMPLANT. THE SURGEON WAS ONLY ABLE TO ASSEMBLE ONE SIDE OF THE IMPLANT. THE AFFECTED STRUT REMAINED WITHIN THE INTRODUCER THAT BENT AS A RESULT OF TRYING TO TURN THE IMPLANT. THE SURGEON EXPLANTED THE IMPLANT AND REPLACED THE CONSTRUCT WITH A MEDIUM IMPLANT. THERE WAS A SURGICAL DELAY OF 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTRACTER - SMALL - 08MM INFIX KWP ABBOTT SPINE 21XR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention