BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4173707 · Received October 15, 2014

    Report

    Report Number
    1030489-2014-04035
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    July 6, 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)(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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013: THE PATIENT UNDERWENT A MRI OF THE LUMBAR SPINE DUE TO LOW BACK PAIN WITH BILATERAL EXTREMITY PAIN AND PARESTHESIAS IN THE LEGS. IMPRESSION: SIGNIFICANT DEXTROSCOLIOSIS WITH THE APEX AT THE LEVEL OF L1. THE SCOLIOSIS EXTENDS INTO THE LOWER THORACIC REGION. THE SCOLIOSIS CREATES ASYMMETRY OF THE DISCS AT T10-11, T11-12, T12-L1 AND L1-2. THERE IS ALSO ROTATORY SCOLIOSIS WITH THE VERTEBRAL BODIES ROTATING TO THE LEFT WITH THE APEX AT THE LEVEL OF L4; THERE ARE PEDICULAR SCREWS IN GOOD POSITION AT L4, L5, AND S1; LAMINECTOMY AT L5 AND PERHAPS INVOLVING THE INFERIOR ASPECT OF THE LAMINA OF L4. THERE IS GRADE 1 ANTEROLISTHESIS OF L5 OVER S1. THERE IS NO CENTRAL CANAL STENOSIS. THERE IS FACET ARTHROSIS THROUGHOUT. THERE IS BILATERAL ENCROACHMENT OF THE NEURAL FORAMINA IN A PROMINENT FASHION. IT WAS REPORTED THAT THE PATIENT DEVELOPED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    Description of Event or Problem · 1

    PER MEDICAL RECORDS, ON (B)(6) 2008 THE PATIENT UNDERWENT A FUSION PROCEDURE AT BACK AREA USING RHBMP-2/ACS, REDUCTION SCREWS, SET SCREWS AND RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654123 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110701AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other