BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191865 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02562
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    November 28, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL APPROACH L3-S1 FUSION USING RHBMP-2/ACS MIXED WITH AUTOGRAFT AND MASTERGRAFT AT MULTIPLE LEVELS ALONG WITH ¿THE IMPROPER INSTRUMENTATION.¿ 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 HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2004: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L3-L5 LUMBAR STENOSIS WITH BILATERAL FORAMINAL AND LATERAL RECESS STENOSIS. BILATERAL L5 AND L4 RADICULOPATHIES. MECHANICAL LOW BACK PAIN REFRACTORY TO MEDICAL THERAPY. STATUS POST LEFT L3-4, L4-5 AND L5-S1 FORAMINOTOMIES PERFORMED IN 1988 ELSEWHERE. FAILED CONSERVATIVE THERAPY. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: RE-DO L3, 4 AND 5 DECOMPRESSIVE LUMBAR LAMINECTOMIES WITH BILATERAL FORAMINOTOMIES, RE-DO ON THE LEFT SIDE, NEW ON THE RIGHT SIDE. L3-S1 POSTEROLATERAL ARTHRODESIS WITH COMBINATION OF AUTOGRAFT, ILIAC CREST GRAFT, RHBMP-2, AND BONE GRAFT. L3-S2 SEGMENTAL PEDICLE SCREW FIXATION SYSTEM, TOTAL OF 8 SCREWS, 2 RODS, AND 2 CROSS-LINKS FOR ADDITIONAL ROTATIONAL STABILITY. LEFT ILIAC CREST BONE GRAFT HARVESTED THROUGH A SEPARATE INCISION. PER OP NOTES, DORSAL ELEMENTS OF L3-S1 WERE EXPOSED IN A SUBPERIOSTEAL FASHION OUT TO THE TRANSVERSE PROCESSES BILATERALLY. THE BONE WAS MORCELLIZED AND LATER PACKED OVER THE TRANSVERSE PROCESSES ON THE LEFT SIDE, DIRECTLY ON THE TRANSVERSE PROCESSES WITH A COMBINATION OF RHBMP-2 AND BONE GRAFT AND ON THE TOP OF BONE GRAFT. ON THE RIGHT SIDE SURGEON PLACED THE RHBMP-2 BONE GRAFT DIRECTLY ON THE DECORTICATED TRANSVERSE PROCESSES AND PACKED AUTOGRAFT OVER IT. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290414 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 47 YR Required Intervention