BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3840811 · Received May 30, 2014

    Report

    Report Number
    1030489-2014-02668
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 21, 2014
    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.

    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) 2011: THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSES: L5/S1 SPONDYLOLISTHESIS WITH BILATERAL L5 PARS DEFECTS; L5/S1 LUMBAR STENOSIS; L4/5 DEGENERATIVE DISC DISEASE WITH HERNIATION; SPINAL INSTABILITY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. BILATERALL5/S1 SEMIHEMILAMINECTOMY, MEDIAL FACETECTOMY AND PROXIMAL FORAMINOTOMY (GILL PROCEDURE) 2. BILATERAL L4/5 SEMIHEMILAMINECTOMY, MEDIAL FACETECTOMY AND PROXIMAL FORAMINOTOMY 3. L4/5 POSTERIOR LUMBAR INTERBODY FUSION WITH ACROMED INTERBODY DEVICE AND MASTERGRAFT 4. L4/L5/S1 POSTERIOR SEGMENTAL INSTRUMENTATION 5. L4/L5/S1 POSTERIOR/LATERAL ARTHRODESIS WITH LOCALLY HARVESTED BONE GRAFT, MASTERGRAFT AND INFUSE (BONE MORPHOGENIC PROTEIN) 6. MICROSURGICALLY ASSISTED DISSECTION 7. INTRAOPERATIVE INTERPRETATION OF RADIOGRAPHIC STUDIES 8. INTRATHECAL INJECTION OF DURAMORPH. PER OP NOTES, THE POSTEROLATERAL ELEMENTS WERE CAREFULLY DECORTICATED AND A COMBINATION OF LOCALLY HARVESTED MORSELIZED BONE GRAFT, MASTERGRAFT AND INFUSE WERE USED TO ACHIEVE ARTHRODESIS. A METICULOUS INTERNAL DISCECTOMY WAS PERFORMED. THE ENDPLATES WERE PREPARED BY SEQUENTIALLY INSERTING INTO THE DISC SPACE THE SHAVERS FOLLOWED BY THE PITUITARY RONGEURS AND CURETTES. THE ACROMED PEEK CAGE WAS PACKED WITH INFUSE (BONE MORPHOGENIC PROTEIN) AND WAS THEN INSERTED INTO THE L4/5 INTERSPACE, BEING COUNTERSUNK TO A DEPTH OF ~ 2 MILLIMETERS AND DIRECTED ACROSS THE MIDLINE IN "TLIF' FASHION. DISTRACTION WAS RELEASED AND GENTLE DISTRACTION APPLIED AT THE L4/5 LEVEL AND THE NERVE ROOTS WERE AGAIN INSPECTED. NO PATIENT COMPLICATIONS WERE REPORTED. (B)(6) 2011: INTRAOPERATIVE X-RAYS WERE PERFORMED AND INTERPRETED THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318218 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