BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFIX

    MDR report key: 842422 · Received April 27, 2007

    Report

    Report Number
    1649384-2007-00028
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    March 23, 2007
    Report Date
    April 25, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE EXPLANTED PRODUCT, NOR LOT NUMBERS WERE MADE AVAILABLE TO ABBOTT SPINE. BASED ON A REVIEW OF THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE CERVICAL PLATE AND SCREWS ARE A CONTRIBUTING FACTOR TO THE FAILURE TO FUSE.

    Description of Event or Problem · 1

    IN 2007, A PATIENT UNDERWENT REVISION SURGERY OF THE CERVICAL SPINE DUE TO PSEUDOARTHROSIS. THE REPORTER STATED THAT THE GRAFT WAS NO LONGER VISIBLE. THE MANUFACTURER OF THE GRAFT IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFIX ANTERIOR CERVICAL CONSTRUCT KWQ ABBOTT SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention