BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3894784 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02901
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    March 9, 2018
    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)(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 UNDERWENT A L4 TO L5 FUSION PROCEDURE USING RHBMP-2/ACS ON (B)(6) 2013. PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN IN HIS LOWER BACK AND LOWER EXTREMITIES. IT WAS REPORTED THAT THE PATIENT BEGAN TO SUFFER FROM RETROGRADE EJACULATION FOLLOWING HIS SURGERY. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING PAIN THAT RADIATES INTO HIS LOWER EXTREMITIES. HE CONTINUES TO SUFFER FROM RETROGRADE EJACULATION, RENDERING HIM STERILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: SPINAL STENOSIS. RECURRENT DISC HERNIATION. DEGENERATIVE DISC DISEASE L4-5. IMMEDIATELY STATUS POST ANTERIOR LUMBAR INTERBODY FUSION L4-5 AND UNDERWENT THE FOLLOWING PROCEDURES: REVISION LAMINECTOMY L4 AND L5. RIGHT L5 NEUROLYSIS. SEGMENTAL PEDICLE SCREW INSTRUMENTATION L4 AND L5 BILATERALLY. POSTEROLATERAL FUSION L4-5. AS PER OP-NOTES,¿ A PEDICLE PROBE CREATED TRACT THROUGH THIS PEDICLE, WHICH WAS CONFIRMED WITH A BALLPOINT PROBE, A 5.5 TAP, AND ULTIMATELY 6.5 X 45 MM SCREWS WERE UTILIZED. PRIOR TO PLACEMENT OF THE SCREW, A HIGH-SPEED BUR THOROUGHLY DECORTICATED THE TRANSVERSE PROCESS OF THE CORRESPONDING PEDICLE, AS WELL AS THE FACET AT L4-5. NEURO-MONITORING TESTING SHOWED ALL SCREWS MET ACCEPTABLE THRESHOLDS. AP AND LATERAL RADIOGRAPH CONFIRMED THE APPROPRIATE PLACEMENT OF ALL INSTRUMENTATION. ULTIMATELY, A 40 MM ROD WAS PLACED IN THE SCREW HEADS, CAPS PLACED AND TORQUED TO MANUFACTURER'S SPECIFICATION. THE WOUND WAS COPIOUSLY IRRIGATED WITH GREATER THAN 1 L OF ANTIBIOTIC-LADEN SOLUTION. HALF OF BONE MORPHOGENIC PROTEIN IN EACH POSTEROLATERAL GUTTER DIRECTLY UNDER THE TRANSVERSE PROCESS, ALONG WITH 30 ML OF CANCELLOUS CHIPS AND LOCALLY HARVESTED AUTOGRAFT LAMINECTOMY.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369941 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