BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3736873 · Received April 9, 2014

    Report

    Report Number
    1030489-2014-02134
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    June 21, 2016
    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): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT: BILATERAL PARTIAL L3, COMPLETE L4, AND PARTIAL L5 DECOMPRESSIVE LAMINECTOMIES. LEFT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-4 AND L4-5 USING PEEK CAGE, BONE MORPHOGENIC PROTEIN, MORSELLIZED ALLOGRAFT, AND LOCAL AUTOGRAFT. RIGHT POSTEROLATERAL FUSION FROM L3 TO L5 USING BONE MOPHOGENIC PROTEIN, MORSELLIZED ALLOGRAFT AND LOCAL AUTOGRAFT. PEDICLE SCREWS PLACED BILATERALLY FROM L3 TO L5 USING STEALTH IMAGE-GUIDANCE. O ARM USED FOR INTRAOPERATIVE CT. MICROSCOPE USED FROM MICRODISSECTION. PREOPERATIVE DIAGNOSIS: L3-4 AND L4-5 INSTABILITY WITH SEVERE CENTRAL CANAL STENOSIS. PER-OP NOTES: "THE DISC SPACES WERE PREPARED WITH CURVED CURETTES AND PITUITARY RONGEURS. POSTERIOR OSTEOPHYTES IN THE DISC SPACE WERE REMOVED WITH THE KERRISON RONGEURS. A LARGE IT OF BMP WAS USED FOR THIS CASE, AND COLLAGEN SPONGES WERE SOAKED IN BMP FOR APPROXIMATELY 1HR. A 1X1 CM PIECE OF BMP SPONGE AS WELL AS MORSELLIZED ALLOGRAFT MIXED LOCAL AUTOGRAFT WAS PACKED IN THE ANTERIOR CONTRALATERAL PORTION OF EACH DISC SPACE. A 10X22MM PEEK CAGE WAS SIZED IN EACH SPACE. THIS WAS VERY LOOSELY PACKED WITH BMP. MORE BONE GRAFT MATERIAL WAS PACKED BEHIND THIS. "IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT: BILATERAL PARTIAL L3, COMPLETE L4, AND PARTIAL L5 DECOMPRESSIVE LAMINECTOMIES. LEFT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-4 AND L4-5 USING PEEK CAGE, BONE MORPHOGENIC PROTEIN, MORSELLIZED ALLOGRAFT, AND LOCAL AUTOGRAFT. RIGHT POSTEROLATERAL FUSION FROM L3 TO L5 USING BONE MORPHOGENIC PROTEIN, MORSELLIZED ALLOGRAFT AND LOCAL AUTOGRAFT. PEDICLE SCREWS PLACED BILATERALLY FROM L3 TO L5 USING STEALTH IMAGE-GUIDANCE. O ARM USED FOR INTRAOPERATIVE CT. MICROSCOPE USED FROM MICRODISSECTION. PREOPERATIVE DIAGNOSIS: L3-4 AND L4-5 INSTABILITY WITH SEVERE CENTRAL CANAL STENOSIS. PER-OP NOTES: "THE DISC SPACES WERE PREPARED WITH CURVED CURETTES AND PITUITARY RONGEURS. POSTERIOR OSTEOPHYTES IN THE DISC SPACE WERE REMOVED WITH THE KERRISON RONGEURS. A LARGE IT OF BMP WAS USED FOR THIS CASE, AND COLLAGEN SPONGES WERE SOAKED IN BMP FOR APPROXIMATELY 1HR. A 1X1 CM PIECE OF BMP SPONGE AS WELL AS MORCELLIZED ALLOGRAFT MIXED LOCAL AUTOGRAFT WAS PACKED IN THE ANTERIOR CONTRALATERAL PORTION OF EACH DISC SPACE. A 10X22MM PEEK CAGE WAS SIZED IN EACH SPACE. THIS WAS VERY LOOSELY PACKED WITH BMP. MORE BONE GRAFT MATERIAL WAS PACKED BEHIND THIS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TLIF AT L3-4, L4-5 USING PEEK CAGES, RHBMP-2/ACS, MORCELLIZED ALLOGRAFT, AND LOCAL AUTOGRAFT; RIGHT PLIF L3- L5 USING BMP, MOCELLIZED ALLOGRAFT, AND LOCAL AUTOGRAFT. THE TRANSVERSE PROCESSES FROM L3 TO L5 WERE ALSO DISSECTED OUT. BMP AS WELL AS MORCELLIZED ALLOGRAFT MIXED WITH LOCAL AUTOGRAFT WAS PACKED IN THE ANTERIOR CONTRALATERAL PORTION OF EACH DISKSPACE. A CAGE WAS SIZED IN EACH DISK SPACE. THIS WAS VERY LOOSELY PACKED WITH BMP. MORE BONE GRAFT WITH LOCAL AUTOGRAFT WAS PACKED IN THE ANTERIOR CONTRALATERAL PORTION OF EACH DISK SPACE. MORE BONE GRAFT MATERIAL WAS PACKED BEHIND THIS. THE REST OF THE BMP WAS ROLLED IN BONE GRAFT AND PLACED POSTEROLATERALLY ON THE RIGHT FROM L3 TO L5. SOMETIME POST OP, THE PATIENT REPORTEDLY SUFFERED NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214793 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110810AA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other