BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3071108 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01184
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    January 9, 2017
    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

    (B)(4).

    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 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

    IT WAS REPORTED THAT ON (B)(6) 2007, PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION AND POSTEROLATERAL FUSION FROM VERTEBRAE L5 TO S1. REPORTEDLY, THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS IN THIS SURGERY. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE LATERAL GUTTERS). ALLEGEDLY, "PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY A PERIOD OF IMPROVEMENT, FOLLOWED BY RECURRENT BACK PAIN AND RADICULOPATHY. DUE TO SEVERE PAIN AND SYMPTOMS, THE PATIENT UNDERWENT THREE REVISION SURGERIES ON (B)(6) 2008, (B)(6) 2009 AND (B)(6) 2012."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172114 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R