BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2832127 · Received November 14, 2012

    Report

    Report Number
    1030489-2012-02182
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    June 26, 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

    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 DEVELOPED "PAIN, MENTAL ANGUISH, AND THE FEAR OF HAVING TO UNDERGO ANOTHER SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: DEGENERATIVE LUMBAR DISC DISEASE WITH HERNIATION AND STENOSIS, L4/L5. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: DECOMPRESSIVE LUMBAR LAMINECTOMY, L4 AND L5; POSTERIOR LUMBAR INTERBODY FUSION, L4/L5 RIGHT; BILATERAL PEDICLE SCREW INSTRUMENTATION, L4/L5; BILATERAL POSTEROLATERAL AUTOGRAFT AND BMP (BONE MORPHOGENIC PROTEIN) FUSION, L4/L5. AS PER OPERATIVE NOTES,¿ THE ANTERIOR PART OF THE DISC SPACE WAS TACKED WITH BMP AND SOME MORCELLIZED AUTOGRAFT BONE WAS SAVED FROM THE DECOMPRESSION. SOME BMP WAS THEN PACKED INTO A 12 X 26 CAGE AND PROGRESSIVELY INSERTED, STARTING LATERALLY AT L4/L5 AND THEN TAKING A MORE ACROSS THE MIDLINE APPROACHING. ¿ 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 M110701AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R