BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2990179 · Received March 5, 2013

    Report

    Report Number
    1030489-2013-00670
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    March 25, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING RHBMP-2/ACS. POST-OP, THE PATIENT REPORTEDLY DEVELOPED "SIGNIFICANT PAIN, MAJOR NERVE INJURIES, AND HAS GIVEN ME PHYSICAL LIMITATIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A POSTEROLATERAL SPINE FUSION SURGERY L5-S1 USING RHBMP-2/ACS. THE PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY INITIAL RELIEF, FOLLOWED BY INCREASINGLY SEVERE PAIN, THAT EVENTUALLY DEVELOPED INTO PARESTHESIAS INCLUDING NUMBNESS AND TINGLING THAT RADIATED THROUGH HER LEFT LOWER EXTREMITY. THE PATIENT UNDERWENT A LUMBAR MRI STUDY ON (B)(6) 2013 THAT IDENTIFIES REACTIVE ENDPLATE CHANGES AT L5 AND S1. IT ALSO FINDS HETEROTOPIC BONE EMERGING FROM IMPLANT SITE THAT NARROWS THE BILATERAL NEUROFORAMEN AT THE L5 TO S1 LEVELS, AND IS THE PATIENT'S PRIMARY PAIN GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94210 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111064AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other