BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3193043 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02586
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    October 10, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-L5 FUSION USING RHBMP-2/ACS. SUBSEQUENTLY, 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 HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2006, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: L4-5 INSTABILITY AND UNDERWENT FOLLOWING PROCEDURES: L4-5 POSTERIOR LUMBAR INTERBODY FUSION. L4 LAMINECTOMY WITH BILATERAL FACETECTOMIES AND FORAMINOTOMIES FOR DECOMPRESSION. L4-5 POSTERIOR SEGMENTAL INSTRUMENTATION. L4-5 POSTEROLATERAL BILATERAL MORCELIZED AUTOGRAFT FUSION. INTRAOPERATIVE INTERPRETATION OF FLUOROSCOPIC IMAGES. PER OP-NOTES: ¿"ONCE THE DISCECTOMY WAS COMPLETED ON EACH SIDE, THEN, WORKING ON THE LEFT AND THE RIGHT RHBMP-2 PREPARATION WAS PLACED ANTERIORLY WITHIN THE DISC SPACE ALONG WITH MORCELIZED AUTOGRAFT CHIPS. TEN MILLIMETRES (10 MM) HEIGHT CAGES WERE THEN PACKED WITH RHBMP-2 AND AUTOGRAFT CHIPS AND THESE WERE THEN PLACED INTO THE INTERBODY SPACE, CONTROLLING THEIR ADVANCEMENT WITH LATERAL FLUOROSCOPY. POSTERIOR TO THE CAGES THEN, MORE MORCELIZED AUTOGRAFT CHIPS WERE PLACED UP TO THE LEVEL OF THE POSTERIOR ASPECT OF THE VERTEBRAL BODY AND THEY WERE PACKED IN. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294690 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 00061 YR Required Intervention