BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3172487 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02333
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    February 29, 2016
    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).

    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

    REPORTEDLY, THE PATIENT IS EXPERIENCING NERVE DAMAGE, NUMBNESS/SEVERE TINGLING IN LOWER LEFT LEG, LEG GIVES OUT.

    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) 2008 THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF L5-S1 STENOSIS WITH LEFT LOWER EXTREMITY RADICULOPATHY AND UNDERWENT FOLLOWING PROCEDURES: L5-S1 POSTERIOR SPINAL FUSION. LEFT SIDED TLIF. APPLICATION OF INTERVERTEBRAL BIOMECHANICAL SPACER INTO THE L5-S1 INTERSPACE. PEDICLE SCREW AND ROD INSTRUMENTATION OF L5 AND S1 LEVELS. ALLOGRAFT CANCELLOUS BONE PLACEMENT. USE OF BMP SMALL KIT. USE OF STRYKER MANTIS PEDICLE SCREW AND ROD SYSTEM, PEEK STRAIGHT CAGE. PER OP NOTES, "..THE SURGEON THEN PREPARED THE ENDPLATES, COPIOUSLY IRRIGATED, PACKED LOCAL BONE IN THE INTERSPACE AS WELL AS ONE OF THE SMALL BMP SPONGES. THE SURGEON THEN PLACED A BMP SPONGE IN THE CAGE ITSELF WITH A STRAIGHT CAGE AND THEN PACKED BONE ALSO WITH THIS BMP IN THE CAGE. THEN PLACED THE PEEK SPACER NOTED TO HAVE A GOOD FIT. THEN THEY PLACED TISSEEL OVER THE INTERSPACE TO SEAL IN THE BMP. WE THEN PLACED SOME DEMINERALIZED CANCELLOUS BONE MATRIX FOR POSTEROLATERAL FUSION..." THE PATIENT SUSTAINED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273291 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110706AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other