BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2831416 · Received November 14, 2012

    Report

    Report Number
    1030489-2012-02163
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    December 22, 2017
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2003: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SPONDYLOLISTHESIS, L4-5 WITH DISC DISEASE L4-5 AND L5-S1, HERNIATION L5-S1; STATUS POST IDET L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: NON-SEGMENTAL INTERNAL FIXATION, L4-5 AND L5-S1 BILATERALLY. POSTEROLATERAL SPINAL FUSION, L4-5 AND L5-S1. HARVESTING RIGHT POSTERIOR AUTOLOGOUS ILIAC CREST GRAFT THROUGH A SEPARATE FASCIAL INCISION. PREPARATION NON-STRUCTURAL ALLOGRAFT. AS PER OPERATIVE NOTES,¿ RONGEURS AND THE MIDAS REX DRILL WERE USED TO DECORTICATE THE LATERAL GUTTERS FROM L4 INTO THE SACRAL ALA AS WELL AS THE POSTERIOR PORTION OF THE FACET JOINTS AT L4-5 AND L5-S1 AFTER WHICH THE BMP(BONE MORPHOGENIC PROTEIN) ALLOGRAFT PREPARATION WAS PLACED WHICH WAS MADE INTO LONGITUDINAL CIGAR TYPE STRIPS WITH CENTER FILLED WITH AUTOGRAFT AND THEN PLACED IN THE LATERAL GUTTER. ADDITIONAL AUTOLOGOUS MORSELIZED BONE GRAFT WAS PLACED OVER HAT AND INTO THE POSTERIOR FACET JOINTS BILATERALLY FROM L4 TO THE SACRUM. THIS WAS IMPACTED INTO PLACE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS.

    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