BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4223552 · Received November 4, 2014

    Report

    Report Number
    1030489-2014-04202
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    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 ON (B)(6) 2010, THE PATIENT PRESENTED WITH PRE-OP AND POST-OP DIAGNOSIS: SPONDYLOLYSIS AND SPONDYLOLISTHESIS L4-5. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL POSTEROLATERAL FUSION WITH PEDICLE SCREW INSTRUMENTATION L4-5 BILATERALLY, TRANSFORAMINAL LUMBAR INTERBODY FUSION, L4-5 BILATERALLY WITH CAGES USING FUSION BONE MORPHOGENETIC PROTEIN, VITOSS BIOACTIVE AND LOCAL BONE GRAFT AND BONE NARROW ASPIRATIONS. PER-OP NOTES: NEEDLE WAS INSERTED DOWN TO THE L4-5 INTERTRANSVERSE MEMBRANE BILATERALLY, FINGER DISSECTION CARRIED DOWN TO THE TRANSVERSE PROCESS OF L4 AND L5, MURPHY BALL PROBES WERE PASSED IN THE FORAMEN AT L4-5 BILATERALLY TO GET THE FLUOROSCOPIC VIEW, , ON THE LEFT SIDE PROBE WAS PASSED TO THE PEDICLE OF L5 IN THE FORAMINAL REGION AT L5-S1, FORAMINECTOMY AND FORAMINECTOMY DECOMPRESSING THE EXISTING L4 NERVE ROOT WERE CREATED TO EXPOSE THE L4-5 DISK SPACE, SIMILAR PROCEDURE WAS CARRIED ON THE RIGHT SIDE, PINS WERE PLACED IN THE LEFT ILIAC CREST, C-ARM WITH STERILE CONTROL WAS USED TO PASS PEDICLE SCREWS AT L4-5 BILATERALLY, INNER SPACE WAS DISTRACTED, PEDICLE SCREW WAS TIGHTENED, ANNULECTOMY WAS CREATED ON THE LEFT SIDE, THE INTERSPACE WAS OPENED UP, SIMILAR BMP PROCESS WAS PERFORMED ON THE RIGHT SIDE, 11 X 9 X 27 LORDOTIC CAGE WAS SELECTED ABOUT 1 AND ¼ BMP SPONGES WERE PLACED INSIDE THE CAGE AND INSERTED IT AND RECESSED IT ON THE RIGHT SIDE ABOUT 2 OR 3 MM DEEP TO THE BACK OF THE BODY OF L4. FLOSEAL WAS THEN PLACED OVER THAT REGION AND SIMILAR PROCEDURE WAS PERFORMED ON THE USING THE SAME 11 X 9 X 27 CAGE AND BMP SPONGE PLACED INSIDE IT, THE OTHER HALF OF THE BMP SPONGE WAS PLACED IN THE INTERSPACE BETWEEN THE TWO CAGES OR IN THE MIDLINE OF THE DISK SPACE AND THEN INSERTED THE CAGE ON THE LEFT SIDE, DISTRACTION WAS RELEASED, RODS WERE PLACED ON THE LEFT SIDE AND ATTACHED THE INNER SCREWS, PROCEDURE WAS DUPLICATED ON THE RIGHT SIDE. ON LEFT SIDE, 5 ML OF VITOSS BIOACTIVE WAS PLACED ALONG THE TRANSVERSE PROCESSES FOLLOWED BY 1 BMP SPONGE AND THEN A SECOND 5 ML OF VITOSS SPONGE. ON THE RIGHT SIDE, BMP SPONGE WAS PLACED ALONG THE TRANSVERSE PROCESSES AND FOLLOWED BY LOCAL BONE GRAFT AND ANOTHER BMP SPONGE. THE LOCAL BONE GRAFT AND VITOSS BIOACTIVE WAS TREATED WITH 15 ML OF BONE MARROW ASPIRATE TAKEN FROM RIGHT AND LEFT ILIAC CREST RESPECTIVELY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF AT L4-5 BILATERALLY WITH INTERBODY CAGES AND BILATERAL POSTEROLATERAL FUSION WITH PEDICLE SCREW INSTRUMENTATION AND RHBMP-2 AT 4-L5. IT WAS REPORTED THAT IMAGING STUDIES SHOWED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH RESULTING NERVE COMPRESSION AT OR NEAR THE IMPLANT SITE. IT WAS REPORTED THAT THE PATIENT DEVELOPED SEVERE INJURIES INCLUDING BUT NOT LIMITED TO CHRONIC PAIN, RADICULITIS, EMOTIONAL DISTRESS, AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707433 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110809AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other