BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2840817 · Received November 20, 2012

    Report

    Report Number
    1030489-2012-02411
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    February 2, 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 WAS PRE-OPERATIVELY DIAGNOSED WITH: POSTOPERATIVE HERNIATED DISC EXCISIONS AT L4-5 AND L5-S1. LUMBAR SPINAL STENOSIS, L4-5 AND L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: LEFT L4-5 LAMINECTOMY AND FORAMINECTOMY. TRANSFORAMINAL INTERBODY FUSION L4-5 AND L5-S1. INSERTION OF MACHINED ALLOGRAFT SPACERS, L4-5 AND L5-S1. POSTERIOR AND POSTEROLATERAL FUSION, L3 TO S1. ONLY OF BONE MORPHOGENIC PROTEIN. MOSS PEDICLE SEGMENTAL FIXATION L3 TO S1. AS PER OP-NOTES,¿ THE L4 SPINOUS PROCESS HAD BEEN LARGELY REMOVED. AFTER EXPOSURE, LAMINECTOMIES WERE PERFORMED, FIRST ON THE LEFT AT L5 AND THEN ON THE LEFT AT L4 AND BEGINNING AT L5 AND THEN AT L4, FORAMINECTOMIES WERE PERFORMED. A LAMINAR SPREADER WAS PLACED BETWEEN THE SPINOUS PROCESSES OF L5- S1 AND THEN LATER L4-5 IN ORDER TO OBTAIN DISTRACTION ACROSS THE DISC SPACE. EACH DISC, BEGINNING WITH L5-S1, WAS ENTERED THROUGH A POSTEROLATERAL ANNULOTOMY. DESICCATED DISC MATERIAL WAS DEBRIDED AT EACH LEVEL AND THEN A DEPUY MACHINED ALLOGRAFT SPACER WAS PLACED TRANSVERSELY AND CENTRALLY IN THE EVACUATED DISC SPACE, FOLLOWING PLACEMENT OF A RHBMP-2/ACS SPONGE ANTERIORLY AND SOMEWHAT TO THE RIGHT.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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