BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3201980 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02882
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    December 1, 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

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2009, PATIENT WAS ADMITTED TO THE FACILITY WHERE THE SURGEON PERFORMED SPINE FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L3 TO L5. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE DISC SPACE AND POSTERIOR ELEMENTS). POST-OP PATIENT REPORTEDLY HAD "LOW BACK PAIN WITH PAIN RADIATING DOWN HER LEGS, MORE SEVERE ON THE RIGHT" . "PATIENT CONTINUES TO EXPERIENCE INCREASED PAIN IN HER LOW BACK, RADICULOPATHY IN HER LEGS, AND PERIPHERAL NEUROPATHY IN HER LEFT FOOT. PATIENT CAN NO LONGER FUNCTION NORMALLY DUE TO HER CHRONIC PAIN AND DAILY PAIN MEDICATIONS" . PATIENT REPORTEDLY "EXPERIENCES DIFFICULTY SITTING, STANDING AND WALKING FOR EXTENDED PERIODS AND USES A CANE TO ASSIST IN AMBULATION".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2009: THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH LUMBAR SPINAL STENOSIS AND LUMBAR DEGENERATIVE DISK DISEASE AND UNDERWENT THE FOLLOWING PROCEDURES: L3 AND L4 LAMINECTOMY, BILATERAL L3-4 AND L4-5 FORAMINOTOMIES FOR STENOSIS, L3-4 AND L4-5 INTERBODY FUSION WITH CAGE, AUTOGRAFT, RHBMP-2/ACS, POSTERIOR SPINAL FUSION L4-L5 WITH SEGMENTAL PEDICULAR INSTRUMENTATION USING PEEK ROD SYSTEM, AUTOGRAFT, ALLOGRAFT, AND RHBMP2, SSEP/EMG MONITORING, USE OF OPERATIVE MICROSCOPE. AS PER THE OPERATIVE NOTES: ¿BOX SCISSORS WERE USED TO OPEN UP THE ENDPLATE AND THEN A COMPLETE DISCECTOMY PERFORMED AT THE L3-4 LEVEL USING A COMBINATION OF DISK CUTTERS, CURETTES, AND RONGEURS. THE DISK MATERIAL WAS IRRIGATED TO REMOVE REMAINING FRAGMENTS. THERE WAS GOOD PUNCTATE BLEEDING FROM THE ENDPLATES. TRIALS WERE SIZED, AND A 14 X 30 MM CAGE WAS SELECTED. A LARGE RHBMP-2/ACS HAD BEEN RECONSTITUTED, ONE SPONGE PLACED WITHIN THE CAGE, AND THEN THE CAGE WAS IMPACTED INTO POSITION, ACHIEVING EXCELLENT RESTORATION OF DISK HEIGHT AND INTERFERENCE FIT. ANOTHER RHBMP-2/ACS SPONGE WAS PLACED BEHIND THE CAGE IN THE DISC SPACE AND REMAINING DISC SPACE WAS FILLED UP TO THE LEVEL OF THE ANNULUS WITH MORCELLIZED LAMINECTOMY BONE. NEXT, IN THE SAME FASHION, THE 4-5 DISC SPACE WAS EXPOSED. THE ANNULUS WAS RESECTED. ENDPLATE CHISEL WAS USED AND A COMPLETE DISCECTOMY WAS PERFORMED IN THE SAME FASHION. TRIALS WERE SIZED, AND A 12 X 30-MM CAGE WAS SELECTED. THIS ONCE AGAIN HAD ONE RHBMP-2/ACS SPONGE PLACED IN THE CAGE, WHICH WAS THEN IMPACTED INTO POSITION, ACHIEVING EXCELLENT RESTORATION OF DISK HEIGHT AND INTERFERENCE FIT, AND ANOTHER SPONGE WAS PLACED IN THE DISK SPACE BEHIND THE CAGE, AND THE REMAINING DISC WAS FILLED UP WITH MORCELLIZED LAMINECTOMY BONE. ONCE AGAIN IT WAS SEALED WITH THROMBIN GELFOAM. THE TWO REMAINING RHBMP-2/ACS SPONGES WERE SPLIT LONGITUDINAL AND A HALF SPONGE WAS PLACED AT EACH INTERSPACE BETWEEN L3-4 AND L4-5 BILATERALLY. MORCELLIZED LAMINECTOMY BONE WAS THEN PLACED ON TOP OF THIS, PEDICLE SCREWS WERE THEN APPLIED USING THE PEEK ROD SYSTEM. NEXT, 6.5 X 40-MM SCREWS WERE PLACED AT L3 AND L4, AND 7.5 X 40-MM SCREWS WERE PLACED AT LS BILATERALLY. ALL HAD EXCELLENT INTERFERENCE FIT. THEN 70-MM PEEK RODS WERE APPLIED BILATERALLY, SET SCREWS APPLIED AND TORQUED TO THEIR APPROPRIATE TENSION. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302580 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