BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3965147 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03348
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    May 16, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LYTIC SPONDYLITIS AT L5-S1. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: RETROPERITONEAL EXPOSURE. L5-S1 DISKECTOMY, INDIRECT CENTRAL DECOMPRESSION. PARTIAL L5 CORPECTOMY. PARTIAL S1 CORPECTOMY. PLACEMENT OF A PEEK INTERBODY GRAFT, GLOBUS, SIZE 21, WITH 15-DEGREE LORDOSIS. ANTERIOR LUMBAR INTERBODY FUSION, L5-S1, USING ALLOGRAFT BONE, BMP , AND DEMINERALIZED BONE MATRIX . ANTERIOR INSTRUMENTATION OF L5-S1 USING SCREW AND WASHER, CANCELLOUS, 25MM FULLY THREADED SCREW. USE OF ALLOGRAFT BONE. USE OF FLUOROSCOPY. USE OF SOMATOSENSORY EVOKED POTENTIAL TRIGGERED ELECTROMYOGRAMS. PER OP-NOTES, A PEEK INTERBODY GRAFT WAS PLACED AT L5-S1. THIS WAS A SIZE 21-MM GRAFT WITH 15-DEGREE LORDOSIS. ALLOGRAFT BONE, BMP , DBM WAS PLACED WITHIN THE INTERBODY CAGE. OBVIOUSLY AN ANTERIOR LUMBAR INTERBODY FUSION WAS DONE AT THESE L5 AND S1 LEVELS. ALLOGRAFT BONE AND INFUSE WAS PLACED AT THIS LEVEL. PATIENT WAS AGAIN PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LYTIC SPONDYLOLISTHESIS, L5-S1. STATUS POST ANTERIOR LUMBAR INTERBODY FUSION, L5-S1, WITH INSTRUMENTATION. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTERIOR SEGMENT INSTRUMENTATION, LS-S1 USING GLOBUS MINIMALLY INVASIVE SCREWS, 6.5 X 45-MM SCREWS. POSTERIOR SPINAL FUSION, L5-S1, BILATERAL FACET JOINTS, WITH ALLOGRAFT BONE. USE OF FLUOROSCOPY. USE OF SOMATOSENSORY EVOKED POTENTIALS-TRIGGERED ELECTROMYOGRAM, SOMATOSENSORY EVOKED POTENTIALS, AND TRIGGERED ELECTROMYOGRAM. USE OF ALLOGRAFT BONE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. THE PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED 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 UNDERWENT SURGERY IN WHICH RHBMP-2/ACS WAS USED.NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440956 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110805AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other