BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3110025 · Received May 13, 2013

    Report

    Report Number
    1030489-2013-01676
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    December 15, 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

    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: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DISC DEGENERATION, LUMBAR SPONDYLOSIS, AND CHRONIC LOW BACK PAIN AND UNDERWENT THE FOLLOWING PROCEDURE: L4-L5 AND L5-S1 ANTERIOR LUMBAR INTERBODY FUSION AND INTERBODY CAGE FIXATION WITH BMP IMPREGNATED BMP SPONGES USING INTRAOPERATIVE FLUOROSCOPY. PRE-OPERATIVELY, AN MRI REVEALED DISC DEGENERATION, DISC SPACE COLLAPSE, AND SPONDYLOTIC CHANGES AT L5-S1 WITH BILATERAL LATERAL RECESS STENOSIS AS WELL AS SOME DISC DEGENERATION AND ANNULAR BULGING AT L4-L5. PROVOCATIVE CT DISCOGRAPHY REVEALED ABNORMAL DISCOGRAMS OF BOTH L4-L5 AND L5-S1 WITH REPRODUCTION OF HIS PAIN IN THE CONCORDANT PATTERN AT BOTH LEVELS. THE PATIENT UNDERWENT THE ABOVE MENTIONED PROCEDURE IN WHICH RHBMP2/ACS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210418 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other