BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT 12 MG

    MDR report key: 3806961 · Received May 1, 2014

    Report

    Report Number
    MW5036046
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    September 24, 2009
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, (B)(6) CHIEF OF SPINE SERVICES AND MEDTRONIC CONSULTANT DR (B)(6) PERFORMED L4-5, L5-S1 TWO-LEVEL LUMBAR FUSION WITH LARGE II INFUSE BONE GRAFT IN COMBINATION WITH TWO INTEGRA HOLLYWOOD NANOMETALENE INTERBODY CAGE SPACERS AND SYNTHES/UNIVERSAL INSTRUMENTATION (RODS, SCREWS, CONNECTORS). SEASPINE AND STRYKER SALES REPS WERE IN ATTENDANCE DURING OPERATIVE PROCEDURE. PT DEVELOPED POST-OPERATIVE COMPLICATIONS THAT HEALTH CARE PROVIDERS FAILED TO DISCLOSE WERE ATTRIBUTED TO KNOWN COMPLICATIONS ASSOCIATED WITH IMPROPER DOSAGE/PREPARATION OF RHBMP-2/ACS SPONGE COMPONENTS OF THE COMBINATION PRODUCT USED IN INDICATIONS NOT CLEARED BY THE FDA, INCLUDING BUT NOT LIMITED TO PERMANENT POSTERIOR BONE RESORPTION AT L4-S1 AND HETEROTOPIC BONE GROWTH THAT ESCAPED OUT OF THE CAGES AT BOTH LEVELS AROUND THE DURA AND THE TRANSVERSING NERVE ROOT. PT REQUIRES REVISION SURGERY DECOMPRESSION AND REMOVAL OF HETEROTOPIC BONE GROWTH AT BOTH LEVELS. ON INFORMATION AND BELIEF THE INFUSE BONE GRAFT COMBINATION PRODUCT PMA 000058 WAS ADULTERATED AND MISBRANDED "WHEN IT THE LT-CAGE COMPONENT WAS UNBUNDLED AND REBUNDLED WITH THE INTEGRA HOLLYWOOD NANOMETALENE INTERBODY CAGE." NOT FDA CLEARED TO BE INTRODUCED INTO INTERSTATE COMMERCE UNTIL MAY 2011 UNDER K102026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261857 INFUSE BONE GRAFT 12 MG INFUSE BONE GRAFT 12 MG NEK MEDTRONIC
    261858 HOLLYWOOD NANOMETALENE HOLLYWOOD NANOMETALENE MAX INTEGRA
    261859 HOLLYWOOD NANOMETALENE HOLLYWOOD NANOMETALENE MAX INTEGRA
    261996 UNIVERSAL INTRUMENTATION RODS KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R| S