BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2859464 · Received December 5, 2012

    Report

    Report Number
    1030489-2012-02587
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    June 6, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT DEVELOPED "SIGNIFICANT PAIN AND [IS] REQUIRED ... TO FREQUENTLY VIST [THE] DOCTOR. [THE PATIENT IS] WORRIED THINGS WILL GET WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: C5-C6 RIGHT DISC HERNIATION; C6 RADICULOPATHY ON THE RIGHT. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: C5-C6 ANTERIOR DISCECTOMY TOTAL WITH DECOMPRESSION AND BILATERAL FORAMINOTOMIES; CS-C6 ANTERIOR CERVICAL FUSION; C5-C6 ANTERIOR INSTRUMENTATION USING THE MYSTIQUE PLATE, 19 MM; APPLICATION OF CAGE, 6 X I LX 14 MM; C-ARM IMAGE INTENSIFIER, ONE HOUR; BMP APPLICATION, ONE-QUARTER OF A SPONGE. AS PER OP-NOTES, ¿ ONCE THE END-PLATES WERE PREPARED ON BOTH CS AND C6, WE SELECTED A 6 X 11 X 14-MM CAGE THAT WAS PACKED WITH ONE-QUARTER OF A SPONGE OF BMP AND THE OSTEOPHYTE BONE GRAFT.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. (B)(6) 2007: THE PATIENT WAS DISCHARGED FROM THE FACILITY.

    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 M110701AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R