BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140497 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02032
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    August 7, 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

    (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) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE L3-L4. L4-L5 AND L5-S1 WITH CERVICAL RADICULOPATHY ON THE LEFT AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY C3-C4, C4-C5, C6-C7, DECOMPRESSION OF THE CORD WITH MICRO DISSECTION AND STABILIZATION WITH TITANIUM PLATE AT EACH LEVEL. AS PER OP-NOTES, ¿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¿ NO INTRA -OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240719 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