BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 17532455 · Received August 12, 2023

    Report

    Report Number
    MW5139363
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PLEASE BE INFORMED THAT SYNTHES RECEIVED A POTENTIAL ADVERSE EVENT ON (B)(6) 2009 REGARDING A NON-SYNTHES PRODUCT: MEDTRONIC BONE KIT INFUSE MEDIUM/510400 IP THE FOLLOWING INCIDENT WAS REPORTED TO SYNTHES AND LOGGED AS COMPLAINT COM-073461. PATIENT WAS FOUND TO HAVE DISCOGENIC DISEASE AT L3-4, L4-5 AND LS-S1 AND DISC HERNIATION TO THE RIGHT AT L4-5. ON (B)(6) 2008 PATIENT HAD A TOTAL DISC ARTHROPLASTY AT L3-4 LEVELS USING SYNTHES PRODISC.L, ANTERIOR LUMBAR INTERBODY FUSION AT L4-S 1, AND L5-S I USING SYNTHES ANTERIOR INSTRUMENTATION AND SYNTHETIC CAGE WITH MEDTRONIC BONE KIT INFUSE MORPHOGENIC PROTEIN. INITIALLY PATIENT DID VERY WELL AND THEN AFTER SIX MONTHS HE BEGAN TO DECLINE WITH INCREASING BACK, HIP, LEG PAIN AND PARESTHESIAS. PATIENT WAS REVISED TO PEDICLE SCREW AND ROD INSTRUMENTATION USING PANGAEA SYSTEM AT L4-S1 LEVELS WITH UNKNOWN BONE PROTEIN. SURGEON ALSO PERFORMED A DECOMPRESSIVE LAMINECTOMY WITH EXTENSIVE FORAMINOTOMIES AT L4, L5, AND S1 FOR CENTRAL AND FORAMINAL DECOMPRESSION. (B)(4) THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784798 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC 510400 IP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown