BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6649405 · Received June 19, 2017

    Report

    Report Number
    1030489-2017-01564
    Event Type
    Injury
    Date Received
    June 19, 2017
    Report Date
    May 22, 2017
    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

    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT UNDERWENT THE FOLLOWING PROCEDURE: L5-S1 MAJOR DISCECTOMY WITH PARTIAL CORPECTOMY. L5-S1 ANTERIOR INTERBODY ARTHRODESIS. L5-S1 INSERTION OF INTERVERTEBRAL DEVICE. L4-5 REMOVAL OF ANTERIOR SPINAL IMPLANT, COMPLICATED DUE TO ENDPLATE VIOLATION AND OBLIQUE NATURE OF THE GRAFT AS WELL AS PARTIAL VIOLATION OF THE SPINAL CANAL AND INCARCERATION OF THE CAGE WITHIN THE INTERVERTEBRAL SPACE. L4-5 EXPLORATION OF ANTERIOR SPINAL FUSION. L4-5 REINSERTION OF INTERVERTEBRAL DEVICE, COMPLICATED DUE TO ENDPLATE WEAR AND THE OSTEOTOMY REQUIRED. L4-5 OSTEOTOMY, COMPLICATED. L3-4 MAJOR DISCECTOMY WITH PARTIAL CORPECTOMY. L3-4 ANTERIOR INTERBODY ARTHRODESIS. L3-4 INSERTION OF INTERVERTEBRAL DEVICE. L3-S1 ANTERIOR PLATE FIXATION. 12. L3-4 POSTERIOR SPINAL FUSION REVISION. L4-5 POSTERIOR SPINAL FUSION REVISION. L5-S1 POSTERIOR SPINAL FUSION REVISION. L3-S1 POSTERIOR SPINAL FUSION EXPLORATION. L3-S1 REMOVAL OF POSTERIOR SPINAL IMPLANTS. COMPLICATED REINSERTION OF L3 PEDICLE SCREWS, COMPLICATED WITH AUGMENTATION OF CEMENT. COMPLICATED REINSERTION OF L4 PEDICLE SCREWS WITH CEMENT AUGMENTATION REQUIRING REPOSITIONING OF SCREW DUE TO LATERAL VIOLATION OF VERTEBRAL BODY. REINSERTION OF POSTERIOR SPINAL IMPLANT L5 COMPLICATED. AGAIN REQUIRING DIFFICULT REINSERTION SCREW WITH MEDIAL VIOLATION OF THE PEDICLE WALL. REINSERTION OF POSTERIOR SPINAL IMPLANTS AT S1, COMPLICATED DUE TO MEDIAL VIOLATION OF THE PEDICLE WALL ON THE RIGHT AT L5. REVISION L4-5 DECOMPRESSION/ LAMINECTOMY, MEDIAL FACETECTOMY, FO RAMINOTOMY. REVISION L5-S1 LAMINECTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY. L5-S1 LAMINECTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY. DUAL REPAIR. HARVEST OF FAT GRAFT. FAT GRAFT APPLICATION TO DUAL REPAIR SITE. MORSELIZED AUTOGRAFT FOR SPINE FUSION. USE OF INTRAOPERATIVE FLUOROSCOPY. INSERTION OF CATHETER FOR PAIN PUMP. APPLICATION OF NON-PROGRAMMABLE PAIN PUMP. INTRAOPERATIVE APPLICATION OF AMNIOTIC MEMBRANE DURING SPINAL SURGERY. INDICATIONS: THE PATIENT HAD INCREASING BACK PAIN AND LOWER EXTREMITY DYSFUNCTION PRIMARILY IN THE L5 DISTRIBUTION AS WELL AS THE S1 DISTRIBUTION IN THE LEFT LOWER EXTREMITY. THE PATIENT WAS ALSO NOTED TO HAVE MALPLACEMENT/ SHIFTING OF THE GRAFT, WHICH HAD BEEN PLACED IN THE INTERBODY SPACE.THE PATIENT WAS ALSO NOTED TO HAVE PSEUDOARTHROSIS FROM L3 TO S1 WITH NO POSTEROLATERAL FUSION OR CONSOLIDATION OF THE GRAFT MATERIAL. THE MALPLACED GRAFT ALSO VIOLATED THA CAGE, WHICH VIOLATED THE ENDPLATES OF L4 AND L5 AND A SOFT TISSUE DENSITY AT THE L4-L5 LEVEL IN THE ANTERIOR PORTION OF THE SPINAL CANAL DISPLACING THE THECAL SAC. THE PATIENT ALSO HAD COMPRESSION IN THE LEFT L4-L5 AND S1 NERVE ROOT AS A RESULT OF NEURAL FORAMINAL STENOSIS, LATERAL RECESS STENOSIS AND MALPLACED CAGE AND EPIDURIAL FIBROSIS. AS PER THE OP NOTES: ¿OUR GRAFT WAS APPROPRIATELY HYDRATED AND A HALF STRIP OF RHBMP -2 WAS PLACED IN THE CENTRAL CHANNEL OF THE GRAFT AND CAPPED CRANIALLY AND CAUDALLY WITH DBM PUTTY AND CANCELLOUS MIXED ALLOGRAFT. THE ANNULUS AT L5-S1 WAS CAREFULLY PERFORMED WITH AN 11 BLADE ON A LONG HANDLE SAVING ONLY A SMALL RIM OF LATERAL ANNULUS TO PREVENT OVERDISTRACTION¿. WE APPLIED RHBMP -2 SATURATED SPONGE FOLLOWED BY DBM PUTTY AND CANCELLOUS MIXED ALLOGRAFT AND SCREWS AND DBM STRIPS TO FULLY COMPLETE OUR BONE GRAFT EXTENSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430608 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 52 YR Other