BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERBODY DEVICE

    MDR report key: 1251944 · Received December 3, 2008

    Report

    Report Number
    1030489-2008-00643
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    August 8, 2008
    Report Date
    October 31, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT IN 2007, THE PT UNDERWENT A SURGICAL PROCEDURE AT C3, C4 AND C5 WHERE RHBMP- 2/ACS, MEDTRONIC DISC SPACERS, AND GELFOAM SPONGES WERE IMPLANTED. IT WAS ALSO REPORTED THAT POST-OP, "THE DISC SPACERS AT ALL THREE LEVELS HAD MIGRATED INTO THE SPINAL CANAL CONTUSING AND COMPRESSING THE SPINAL CORD." THE PHYSICIAN REPORTEDLY INFORMED THE FAMILY THAT THE COMPLICATIONS WERE DUE TO PREEXISTING STENOSIS. THE PT UNDERWENT A SURGICAL REVISION FIVE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERBODY DEVICE NONE NEK WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention