BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3031573 · Received April 2, 2013

    Report

    Report Number
    1030489-2013-00918
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    August 14, 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

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS 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 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) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: LOW BACK AND LEG PAIN SYNDROME. LUMBAR SPONDYLOSIS. LUMBAR DISC HERNIATION, L4-L5, LEFT SIDE. LUMBAR STENOSIS. NON-INSULIN-DEPENDENT DIABETES MELLITUS. HYPERTENSION. HISTORY OF STROKE. OBESITY WITH BODY MASS INDEX OF 32. RHEUMATOID ARTHRITIS REQUIRING IMMUNOSUPPRESSIVE THERAPY. THROMBOCYTOPATHY SECONDARY TO PLAVIX AND UNDERWENT THE FOLLOWING PROCEDURES: GILL PROCEDURE AT L4. SEMI- HEMALICTOMY (INFERIOR), L3. FORAMINOTOMIES, BILATERAL, AT: L3-4 AND L4-L5. DISCECTOMY LEFT L4-L5. INTERNAL STABILIZATION FROM L3 THROUGH S1, BILATERAL, USING A PEDICLE SCREW AND ROD SYSTEM (STRYKER- XIA). LATERAL MASS FUSION FROM L3 THROUGH S1, BILATERAL, USING AUTOGENOUS BONE PLUS AUTOLOGOUS BONE PLUS BONE MORPHOGENIC PROTEIN. PREPARATION OF BONE GRAFT. INTRAOPERATIVE FLUOROSCOPY. AS PER OP-NOTES, ¿A PIECE OF GELFOAM WAS PLACED OVER THE EXPOSED THECAL SAC AND EXITING ROOTS TO PREVENT ENTRY OF BONE MORPHOGENIC PROTEIN. RHBMP-2 WAS RECONSTITUTED ACCORDING TO SUPPLIER¿S INSTRUCTIONS AND ALLOWED TO ASSIMILATE FOR MORE THAN 30 MINUTES. IT WAS PLACED OVER THE BONE GRAFT FROM L3 TO S1 ON BOTH SIDES.¿ PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135067 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110612AAO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other