BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3122398 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01806
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    June 20, 2018
    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)(6). (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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 7510200, LOT: M110706AAJ; QTY: 2). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DISCOGENIC SYNDROME LUMBAR HERNIATED NUCLEUS PULPOSUS AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR ENDOSCOPIC MINIMALLY INVASIVE HEMILAMINECTOMY AND BILATERAL DISCECTOMY AT L5-S1 FOR NERVE ROOT DECOMPRESSION POSTERIOR MINIMALLY INVASIVE INTERBODY ARTHRODESIS L5-S1 WITH MACROPORE PROSTHESIS AND BONE MORPHOGENIC PROTEIN. POSTERIOR BILATERAL LATERAL FUSION L5-S1 WITH ALLOGRAFT AND BONE MORPHOGENIC PROTEIN INSERTION OF PEDICLE SCREW FIXATION L5-S1 WITH REVER MULTIAXIAL SCREW FIXATION PREPARATION OF ALLOGRAFT. AS PER OP-NOTES,¿ WITH THE NERVE ROOTS SAFELY RETRACTED, A BOX OSTEOTOME WAS THEN USED IN ORDER TO CUT A CHANNEL IN THE ENDPLATES OF L5 AND S1 THROUGH A CONTROLLED DEPTH OF 35 MM USING LATERAL FLUOROSCOPIC GUIDANCE. EXCESS BONE AND SOFT TISSUE WAS THEN REMOVED. THIS WAS FOLLOWED BY PLACEMENT OF A 12 MM MACROPORE PROSTHESIS FILLED WITH COLLAGEN SPONGE PREPARED WITH BONE MORPHOGENIC PROTEIN. AFTER PLACEMENT OF THE PROSTHESIS, THE CONTRALATERAL DISTRACTOR WAS REMOVED AND A 2ND IDENTICALLY PREPARED PROSTHESIS INSERTED ON THE OPPOSITE SIDE. AFTER COMPLETION OF THE INTERBODY FUSION, MINIMALLY INVASIVE PEDICLE SCREW FIXATION WAS PERFORMED IN THE FOLLOWING FASHION: HIGH SPEED DRILL WAS USED IN ORDER TO ENTER THE PEDICLE DORSALLY ON THE LEFT AT L5, PROBE WAS THEN PASSED DOWN THE PEDICLE AND TESTED BY THE ELECTROPHYSIOLOGY TECHNICIAN PRESENT TO CONFIRM ABSENCE OF EVIDENCE OF A BREACH. THE PROBE WAS REMOVED AND THE PEDICLE TAPPED, FOLLOWED BY INSERTION OF A 5.5 X 40 MM REVERE MULTIAXIAL PEDICLE SCREW. THE SCREW WAS TESTED IN PLACE AND FOUND TO BE WITHOUT EVIDENCE OF A BREACH. USING IDENTICAL TECHNIQUE, A 5.5 X 40 MM SCREW WAS INSERTED ON THE RIGHT AT LS AND 6.5 X 35 MM SCREWS BILATERALLY AT S1. ALL PROBES AND SCREWS WERE TESTED AND FOUND TO BE WITHOUT EVIDENCE OF A BREACH. FINAL FLUOROSCOPIC IMAGES CONFIRMED E XCELLENT PLACEMENT AND INSTRUMENTATION AT THE APPROPRIATE LEVELS. LORDOTIC RODS WERE THEN SELECTED OF THE APPROPRIATE LENGTH AND AFFIXED TO THE MULTIAXIAL SCREW HEAD WITH CAPS TO SECURE THE RODS IN THE USUAL FASHION. BILATERAL POSTEROLATERAL ARTHRODESIS WAS THEN PERFORMED THROUGH THE ENDOSCOPIC RETRACTOR SYSTEM BY 1ST USING A HIGH-SPEED DRILL TO DECORTICATE THE TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA ON BOTH SIDES. THIS WAS THEN FOLLOWED BY PLACEMENT OF 2 PREPARATIONS OF ALLOGRAFT PUTTY WRAPPED IN COLLAGEN SPONGE PREPARED WITH BONE MORPHOGENIC PROTEIN. PREPARATIONS WERE PLACED FROM L5 TO THE SACRUM BILATERALLY.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224458 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110706AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other