BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4171433 · Received October 14, 2014

    Report

    Report Number
    1030489-2014-04030
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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.

    Description of Event or Problem · 1

    ETHNICITY : NON-HISPANIC. THE PATIENT UNDERWENT FUSION SURGERY AT ANTERIOR LUMBAR SPINE USING RHBMP-2/ACS, ALIF SPACER, SCREWS, WASHER AND SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT PRESENTED WITH BILATERAL LOWER EXTREMITY PAIN AND LOW BACK PAIN STATUS POST PREVIOUS SURGERY. AN MRI OF THE LUMBAR SPINE INDICATED ¿CHANGES STATUS POST ANTERIOR AND POSTERIOR FUSION AT L5-S1. PEDICLE SCREWS ARE IN EXCELLENT POSITION AT L5 AND S1 AND THERE IS AN ANTERIOR FUSION PLATE ALSO WELL LOCATED. INTERBODY FUSION IMPLANT IS PRESENT AND IS ALSO VERY WELL LOCATED IN THE CENTRAL PORTION OF THE DISK. UNUSUAL MULTILOBULAR FLUID COLLECTION IN THE L5-S1 DISK INTERSPACE ASSOCIATED WITH THE FUSION IMPLANT. I DO NOT BELIEVE THAT THIS IS INFECTIOUS AS THERE ARE NO OTHER SIGNS OF INFECTION SUCH AS EDEMA OR ENHANCEMENT. THERE IS NO NEUROLOGIC IMPINGEMENT.¿ IT WAS REPORTED THAT THE PATIENT DEVELOPED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650529 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110804AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other