BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3013747 · Received March 20, 2013

    Report

    Report Number
    1030489-2013-00816
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    December 27, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT EXPERIENCED "COMPLICATIONS SUCH AS PAIN, PHYSICAL LIMITATIONS, AS WELL AS A NEED FOR A REVISION SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SEVERE DISC DEGENERATION L4-5, L5-S1. DISC HERNIATIONS L4-5, L5-S1. SPINAL STENOSIS. LUMBAR RADICULOPATHY; AND UNDERWENT THE FOLLOWING PROCEDURES: LAMINECTOMY WITH BILATERAL FORAMINOTOMIES L4. LAMINECTOMY WITH BILATERAL FORAMINOTOMIES L5. LAMINECTOMY WITH BILATERAL FORAMINOTOMIES S1. 4) POSTERIOR LATERAL FUSION L4-5. POSTERIOR LATERAL FUSION L5-S1. SEGMENTAL PEDICLE SCREW INSTRUMENTATION L4, L5, S1-2. LOCAL AUTOGRAFT. USE OF BONE MORPHOGENIC PROTEIN. ON (B)(6) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH JUNCTIONAL SPINAL STENOSIS, L3-4. POST LAMINECTOMY SYNDROME. PS EUDOARTHROSIS, L4-5 AND L5-S1. LUMBAR RADICULOPATHY. HE UNDERWENT THE FOLLOWING PROCEDURES: LAMINECTOMY WITH BILATERAL FORAMINOTOMIES, L3. REVISION LAMINECTOMY WITH BILATERAL FORAMINOTOMIES, L4. IN SITU POSTEROLATERAL FUSION, L3-4, L4-5, AND L5-S1. REMOVAL OF SEGMENTAL PEDICLE SCREW INSTRUMENTATION. EXPLORATION OF FUSION. LOCAL AUTOGRAFT. BONE MORPHOGENIC PROTEIN. AS PER OP-NOTES, "LOCAL BONE HARVESTED DURING OUR LAMINECTOMIES WAS MORCELLIZED, CLEARED OF SOFT TISSUE, AND SOAKED IN ANTIBIOTIC IRRIGANT. A LEKSELL RONGEUR WAS USED TO DECORTICATE THE BILATERAL TRANSVERSE PROCESSES OF L3 AND ROUGHEN UP THE PREVIOUSLY-PLACED FUSION MASS AT L4-5 AND L5-S1. BONE MORPHOGENIC PROTEIN WITH HYDROXYAPATITE WAS THEN PACKED IN THE GUTTERS, SPANNING TRANSVERSE PROCESSES AT L3, L4, L5, AND S1. LOCAL AUTOGRAFT WAS PLACED OVER THE BONE MORPHOGENIC PROTEIN. THE DURA WAS CAREFULLY INSPECTED FOR CSF LEAKAGE, AND THERE WAS NONE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115227 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 Required Intervention