BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3840760 · Received May 30, 2014

    Report

    Report Number
    1030489-2014-02665
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    August 15, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE AT L4-5 ON (B)(6) 2005. THE SURGEON PERFORMED AN L4-5 DISCECTOMY, AN ANTERIOR LUMBAR INTERBODY FUSION AT L4-5 USING A SYNTHETIC FUSION CAGE AND A POSTEROLATERAL FUSION WITH INSTRUMENTATION. THE CAGE WAS PACKED WITH CERAMIC GRANULES, AUTOGRAFT BONE, AND RHBMP-2/ACS. BMP2 WAS ALSO PLACED IN THE TRANSVERSE PROCESSES. FOLLOWING SURGERY, PATIENT FOLLOWED UP WITH HIS PHYSICIAN AS HE BEGAN TO DEVELOP RADIATING PAIN TO HIS LEGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005, PATIENT UNDERWENT FOLLOWING SURGERY: STAGE 1: ANTERIOR DISCECTOMY OF L4-5; ANTERIOR SPINAL FUSION OF L4-5; PLACEMENT OF SYNTHETIC CAGE AT L4-5; USE OF LOCAL AUTOGRAFT BONE; USE OF RHBMP-2/ACS; USE OF GRAFT MATRIX. STAGE 2: POSTERIOR SPINAL FUSION AT L4-5; INSTRUMENTATION USING TITANIUM INSTRUMENTATION; HARVESTING RIGHT POSTERIOR ILIAC CREST BONE GRAFT; USE OF RHBMP-2/ACS; USE OF GRAFT MATRIX PRE-OP AND POST-OP DIAGNOSIS: L4-5 DISC PROTRUSION WITH DISCOGENIC PAIN AND RIGHT FORAMINAL STENOSIS. AS PER OP-NOTES: ".. A CAGE OF APPROPRIATE SIZE WAS CHOSEN. IT WAS FILLED WITH LOCAL AUTOGRAFT BONE, BMP AND GRAFT AND IS TAMPED INTO POSITION FOR A GOOD FIT. THE TRANSVERSE PROCESSES ARE DECORTICATED AND GRAFTED USING RHBMP-2 AROUND AUTOGRAFT BONE.. NO COMPLICATIONS WERE REPORTED.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319231 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