BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5333133 · Received December 29, 2015

    Report

    Report Number
    1030489-2015-03601
    Event Type
    Injury
    Date Received
    December 29, 2015
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 ,THE PATIENT UNDERWENT LAMINECTOMY L2-3, L3-4 WITH LAMINECTOMY, FORAMINECTOMY, INFERIOR FACETECTOMY L4-5 AND L5-S1. TRANSFORAMINAL DISCECTOMY L4-5 AND L5-S1. INTERBODY CAGE INSERTION (CAGE WITH BONE MORPHOGENIC PROTEIN) L4-5 AND L5-S1. POSTERIOR LATERAL INTERBODY FUSION WITH LOCAL BONE GRAFT L4-5, L5-S1. POSTERIOR LATERAL SPINAL FUSION WITH LEGACY SEGMENTAL INSTRUMENTATION L1 TO S1. IMPLANTATION OF EBI BONE GROWTH STIMULATOR. PREOPERATIVE DIAGNOSIS: LUMBAR DISC HERNIATION WITH SPINAL STENOSIS, L4-5, L5-S1, LESSER AMOUNTS AT L3-4. LUMBAR SCOLIOSIS. PER-OP NOTES: DECOMPRESSION WAS STARTED DISTALLY AND MOVING PROXIMALLY THE LAMINECTOMY, FORAMINOTOMY AND INFERIOR FACETECTOMY AT L5-S1, FOLLOWED BY L4-5. THERE WAS DEFINITELY SOME LIGAMENTUM FLAVUM HYPERTROPHY. A TRANSFORAMINAL DISCECTOMY WAS CARRIED OUT AT L4-5 AND L5-S1 WITH CURETS, RONGEURS, AND DISC SHAVERS. EACH PEDICLE WAS TAPPED AND PROBED AND NO DISRUPTIONS WERE FOUND. DECORTICATION OF THE TRANSVERSE PROCESSES AND THE OUTER PORTION OF THE FACET JOINTS, AS WELL AS SACRAL ALA, WERE COMPLETED WITH A BUT BILATERALLY. THE LEGACY TRANSPEDICULAR SCREWS WERE THEN PLACED AT EACH LEVEL AND TRIGGERED EMG STIMULATION OF ALL SCREWS WAS NORMAL. AT THE L4-5 AND L5-S1 CAGE FILLER WITH BONE MORPHOGENIC PROTEIN WAS INSERTED INTO THE INTERBODY SPACE. THE POSTERIOR LATERAL INTERBODY FUSION WAS COMPLETED USING LOCAL BONE GRAFT AT BOTH L4-5 AND L5-S1. THIS WAS FOLLOWED BY PLACEMENT OF BONE GRAFTING MATERIAL IN THE POSTERIOR LATERAL GUTTERS, INCLUDING LOCAL BONE GRAFT, BMP AND BONE GRAFT. AFTER THE GENERAL POSTERIOR LATERAL FUSION FROM L1 TO SACRUM, INTRAOPERATIVE X-RAY SHOWED EXCELLENT POSITION OF ALL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856748 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110608AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other