BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2832116 · Received November 14, 2012

    Report

    Report Number
    1030489-2012-02181
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    December 27, 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

    DOB: (B)(6) 1957.

    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.

    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

    REPORTEDLY, THE PATIENT HAS "INJURY INCLUDING PAIN-A DIAGNOSIS OF CANCER, AS WELL AS REQUIRED FREQUENT FOLLOW UPS WITH DOCTOR."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2004: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC COLLAPSE, DISC SPACE L5-S1 WITH FORAMINAL ENCROACHMENT, SEGMENTAL INSTABILITY AT L5-S1; AND UNDERWENT THE FOLLOWING PROCEDURES: 1) DECOMPRESSIVE HEMI-LAMINECTOMY L5-S1 BILATERALLY. 2) DISCECTOMY L5-S1 BILATERALLY WITH INTERBODY FUSION AT L5-S1 USING PEEK AND LARGE BMP-2 KIT AND LOCAL BONE. 3) BILATERAL LATERAL FUSION, L5 TO S1, USING BONE GRAFT, BMP. 4) INTERNAL FIXATION USING INTERNAL FIXATION, L5 TO S1. AS PER OP-NOTES, "ONCE DISK WAS REMOVED USING ROTATING CUTTER, SCRAPER AND A FREE-HAND CHISEL, THE INTERSPACE WAS PREPARED FOR THE GRAFT. A 10 X 22 PEEK CAGE THAT WAS FILLED WITH LARGE BMP-2 SPONGE AND LOCAL BONE THAT HAD BEEN TAKEN THROUGH THE BONE MILL WAS TAKEN AND PLACED INTO THE CAGE AND INSERTED INTO THE INTERSPACE AND COUNTERSUNK. THE SAME WAS DONE ON THE OPPOSITE SIDE. I REMOVED THE DISTRACTOR PLUG. INTERSPACE WAS THEN PREPARED USING ROTATING CUTTERS, FREE-HAND CHISEL AND A SCRAPER TO PREPARE THE SPACE. ONCE THIS WAS DONE, TWO SMALL BMP SPONGES WERE TAKEN AND PLACED IN THE INTERSPACE IN THE MIDLINE. A 10 X 22 PEEK CAGE WAS THEN FILLED WITH LARGE BMP-2 SPONGE, LOCAL BONE AND INSERTED IN THE INTERSPACE AND COUNTERSUNK. ONCE THIS WAS DONE, THERE APPEARED TO BE ADEQUATE DECOMPRESSION OF THE NERVE ROOTS. SOFT TISSUE WAS REMOVED LATERAL TO THE TRANSVERSE PROCESS. THESE WERE IDENTIFIED AT L5 AND THE SACRUM. THESE AREAS WERE THEN DECORTICATED. UNDER FLUOROSCOPIC CONTROL, THE PEDICLES WERE IDENTIFIED AT L5 AND THE SACRUM AND THEY WERE PROBED AND THEY WERE TAPPED AND PEDICLE FIXATION WAS DONE UNDER FLUOROSCOPY. ONCE THIS WAS DONE, CONFIRMATION WAS DONE FLUOROSCOPICALLY. THE COMPRESSION WAS DONE AND WAS HELD IN POSITION USING THE I BOLTS AND THE PRE-BENT RODS. ONCE THIS WAS DONE, THE LARGE BMP SPONGES WITH LOCAL BONE WERE TAKEN AND PLACED IN THE DECORTICATED AREA FROM L5 TO THE SACRUM AND AUGMENTED WITH BONE GRAFT.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Other| R