BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2863288 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02704
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    May 25, 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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    REPORTEDLY, THE PATIENT HAS "CONSTANT AND EXTREME PAIN, AS WELL CONSTANTLY WORRYING ABOUT [PATIENT'S] CONDITION GETTING WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: MULTIPLIED FAILED BACK WITH L5 RADICULOPATHY, SURGERY WITH SEVERE PAIN IN THE RIGHT LEG BULGING DISC L4-L5, RECURRENT DISC. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL DECOMPRESSION LAMINECTOMY L4 WITH BILATERAL FACETECTOMY; BILATERAL PEDICLE SCREWS, L4 AND L5; RADICAL DISCECTOMY AND TRANSFORAMINAL LUMBAR INTERBODY FUSION USING CAGE WITH BMP AND LOCAL BONE GRAFT; BILATERAL PEDICLE SCREWS L4-L5; BILATERAL PREBENT RODS WITH SET SCREWS; LOCAL BONE GRAFT HARVESTING; BILATERAL POSTEROLATERAL FUSION WITH BMP AND LOCAL BONE GRAFT. AS PER OPERATIVE NOTES, ¿ONCE THE DISCECTOMY AND THE END PLATES WERE PREPARED AND CLEANED, WE PLACED RHBMP-2, 6 ML OF LOCAL BONE GRAFT AND THEN A CAGE 12 X 30. WE THEN RELEASED THE DISTRACTION AND PLACED PRESSURE ON THEM AND THEN WE BROKE OF THE SET SCREWS. DECORTICATION OF THE POSTERIOR ELEMENTS WAS ACHIEVED. BMP AND LOCAL BONE GRAFT WAS PLACED BILATERALLY.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE 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| R