BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3963241 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03324
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE AT L4 TO L5 USING RHBMP-2/ACS ON (B)(6) 2006. PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY TEMPORARY RELIEF FOLLOWED BY INCREASINGLY SEVERE LOW BACK PAIN, WITH RADIATING PAIN INTO HER LOWER EXTREMITIES. A CT SCAN TAKEN ON (B)(6) 2009 REVEALED DISC BULGES AT THE LEVEL OF THE RHBMP-2/COLLAGEN SPONGE SURGERY RESULTING IN MODERATE IMPINGEMENT OF HER NERVE ROOTS. A CT SCAN TAKEN ON (B)(6) 2014 REVEALED CALCIFICATION OF THE POSTERIOR DISC SPACE AND FACET HYPERTROPHY CAUSING MODERATE TO SEVERE NEUROFORAMINAL STENOSIS AT THE LEVEL OF THE SURGERY SITE. CURRENTLY, PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING LOW BACK PAIN THAT RADIATES INTO HER LEFT HIP AND BOTH OF HER LOWER EXTREMITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2006 RH-BMP-2 WAS USED TO TREAT THE PATIENT. (B)(6) 2006 THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE AT L4-5. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1) POSTEROLATERAL ARTHRODESIS AT L4-5. 2) POSTERIOR NON SEGMENTAL FIXATION AT L4-5. 3) INTERLAMINECTOMY AT L4-5. 4) ALLOGRAFT AND BONE MORPHOGENIC PROTEIN (BMP). PER OP NOTES: CANCELLOUS ALLOGRAFT CHIPS AND BONE MORPHOGENIC PROTEIN WERE UTILIZED TO FACILITATE THE POSTEROLATERAL FUSION. THE BMP WAS LAID AND IMPACTED INTO THE DECORTICATED FACET JOINT AND POSTEROLATERAL INTERTRANSVERSE PROCESS REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441117 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other