BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3061646 · Received April 16, 2013

    Report

    Report Number
    1030489-2013-01063
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    December 15, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    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 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) 2007, PATIENT WAS ADMITTED TO THE FACILITY WHERE THE SURGEON PERFORMED SPINE FUSION SURGERY USING RHBMP2 ON THE LUMBAR REGION OF HIS SPINE FROM VERTEBRAE L4 TO S1. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE DISC SPACE, POSTEROLATERAL GUTTERS, AND OVER POSTERIOR ELEMENTS). POST-OP, PATIENT REPORTEDLY HAD LOW BACK AND LEG PAIN GREW IN SEVERITY UNTIL HE REQUIRED A REVISION SURGERY ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162165 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110605AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R