BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140539 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02034
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    February 16, 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). 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)(6).

    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

    IT WAS REPORTED THAT ON: (B)(6) 2011 THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: PREVIOUS L5-S1 DISCECTOMY; ADVANCED DEGENERATIVE DISK DISEASE, L5-S1; LUMBAR RADICULOPATHY; WORSENING LOW BACK AND LEG PAIN; RADIOGRAPHIC EVIDENCE OF ARACHNOIDITIS. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: RIGHT TRANSFORAMINAL POSTERIOR INTERBODY FUSION USING PEEK SPACER AND MORCELLIZED LOCAL BONE AND BONE MORPHOGENIC PROTEIN / CELLULOSE SPONGE; LEFT L5-S1 MEDIAL FACETECTOMY WITH DECOMPRESSION OF THE EXITING L5 AND TRAVERSING S1 NERVE ROOT; BILATERAL PEDICLE SCREW FIXATION, L5-S1 WITH PEEK RODS; LEFT POSTEROLATERAL FUSION( FACET AND INTERTRANSVERSE TECHNIQUE) USING MORCELLIZED LOCAL BONE AND BMP SPONGE. PER OP NOTES: ¿ BMP SPONGE WAS DRIED WITH A GAUZE SPONGE AND WRAPPED AROUND THE MORCELLIZED BONE , PLACED MEDIALLY WITHIN DISK SPACE. THE TRIAL IMPLANT WAS PLACED. A 10X26 SPACER WAS FILLED WITH BMP AND BONE IMPACTED TOWARD THE ANTERIOR MIDLINE AND MORE BONE WAS PLACED LATERAL TO IT. THE PEEK RODS WERE SIZED AND PLACED AND COMPRESSED TO ENHANCE LORDOSIS AT THE LEVEL. THE MORCELLIZED BONE AND REMAINING BMP SPONGES WERE PLACED OVER THE TRANSVERSE PROCESS AND SACRAL ALA AND PREPARED DORSAL FACET JOINT AT L5-S1 ON THE LEFT.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TRANSFORAMINAL POSTERIOR INTERBODY FUSION USING PEEK SPACER AND RHBMP-2/ACS, A LEFT L5-S1 FACETECTOMY, A BILATERAL PEDICLE SCREW FIXATION AT L5-S2 WITH PEEK RODS, AND A LEFT POSTEROLATERAL FUSION AT L5-S1 WITH RHBMP-2/ACS. IT WAS REPORTED THAT PATIENT NOW SUFFERS FROM CHRONIC/SEVERE BACK PAIN IN BACK/LEG/BUTTOCK, HAS DIFFICULTY WALKING, NUMBNESS, WEAKNESS, AND HAS EXPERIENCED FALLS. PATIENT NEEDS WALKER/CANE/WHEELCHAIR. PATIENT ALSO SUFFERS FROM ERECTILE DYSFUNCTION, RIGHT LEG GIVING OUT, MUSCLE CRAMPS, TINGLING IN LEG, AND ARACHNOIDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241113 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110911AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other