BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191325 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02545
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HE PATIENT UNDERWENT A CERVICAL FUSION AT C4-C5 <(>&<)> C6-C7. THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT PRESENTED WITH CERVICAL RADICULOPATHY SECONDARY TO HERNIATED INTERVERTEBRAL DISCS AT C4-5 AND C5-6. THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY, LEFT SIDED APPROACH, C4-5, AND C5-6, FOLLOWED BY ARTHRODESIS AT EACH LEVEL WITH INSERTION OF INTER-BODY FUSION DEVICE FOLLOWED BY SEGMENTAL FUSION WITH INSTRUMENTATION AT C4-C6. AS PER-OP NOTES, ¿A 8MM ADVANCED ¿ACF¿ SPACER FILLED WITH RHBMP-2 WAS SELECTED AND AFTER PLACING THE RHBMP-2 INTO THE C5-6 INTER-SPACE, IT WAS DRIVEN TO THE CORRECT POSITION. THEREAFTER, RHBMP-2 WAS PLACED INTO THE C4-5 INTERSPACE AND PLACED LATERALLY. A 7MM ADVANCED ¿ACF¿ SPACER FILLED WITH RHBMP-2 WAS THEN PLACED INTO THE C4-5 INTERSPACE AND DRIVEN TO THE CORRECT POSITION.¿ THE PATIENT WAS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289834 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention