BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2801884 · Received October 23, 2012

    Report

    Report Number
    1030489-2012-01954
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    February 2, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY, "I HAD THE INFUSE IMPLANTED INSIDE OF ME DURING BACK SURGERY AND I SUFFERED SERIOUS INJURY INCLUDING PAIN AND THE NEED TO HAVE ANOTHER SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2006, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DEGENERATIVE DISC DISEASE, LUMBAR DISKOGENIC PAIN AND UNDERWENT L5-S1 ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE USING A 14MM INTERBODY PEEK CAGE, SMALL RHBMP-2 KIT PLACED IN THE PEEK GRAFT, 25MM UNITY LOCKING PLATE WAS USED WITH FOUR SCREWS. 10 ML OF OPTECURE WAS USED IN ADDITION WHERE WHICH RHBMP-2/ACS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Other| R