BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830735 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02156
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    April 6, 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)(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.

    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) 2008, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISK DISEASE L5-S1, L4-5, L3-4 , DE GENERATIVE FACET DISEASE, MECHANICAL BACK PAIN WITH LEFT MORE THAN RIGHT LUMBAR RADICULOPATHY CENTRAL TO THE EXTRUDED L5-S1 DISK, FAILURE OF CONSERVATIVE TREATMENT FOR MONTHS AND UNDERWENT THE FOLLOWING PROCEDURES: LUMBAR DECOMPRESSIVE LAMINECTOMIES, BILATERAL S1, BILATERAL L5, BILATERAL L4 ROOT DECOMPRESSION, LATERAL RECESS DECOMPRESSION, FORAMINOTOMIES, FOLLOWED BY LEFT L5-S1 DISKECTOMY, REMOVAL OF EXTRUDED MIGRATED DISK FRAGMENT FOLLOWED BY 360 FUSION TO INCLUDE INTERBODY FUSION, L5-S1, WITH ACROMED DEPUY CAGE WITH RHBMP-2 AND AUTOLOGOUS GRAFT FOLLOWED BY PEDICULAR SCREW FIXATION L4-L5- S1·BILATERAL WITH ACROMED DEPUY JOHNSON & JOHNSON PEDICULAR SCREW SYSTEM FOLLOWED BY LATERAL BILATERAL MASS FUSION L3·L4-L5-S1 WITH COMBINATION OF RHBMP-2 AND AUTOLOGOUS GRAFT. AS PER OP-NOTES,¿ UNDER FLUOROSCOPY 360 FUSION WAS PERFORMED AT L5-S1 TO INCLUDE IMPLANTATION OF INTERBODY DEVICE WITH ACROMED DEPUY CAGE PACKED WITH RHBMP-2 AND AUTOLOGOUS GRAFT. THEN PEDICULAR SCREW FIXATION WAS PERFORMED AT L4 AND L5 AND S1 BILATERALLY, WITHOUT ANY DIFFICULTY. HARDWARE WAS IN SOLID POSITION. THE CROSSBAR WAS USED. STABILITY WAS NICELY ACHIEVED. AFTER SATISFACTORY DECOMPRESSION AND STABILIZATION, LATERAL MASSES OF L3, L4, L5 AND S1 WAS WELL DECORTICATED AND PACKED WITH COMBINATION OF RHBMP-2 AND AUTOLOGOUS GRAFT.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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