BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3052130 · Received April 11, 2013

    Report

    Report Number
    1030489-2013-00992
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    July 3, 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

    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

    IT WAS REPORTED THAT ON: (B)(6) 2012: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L4-5 HIGH GRADE STENOSIS AND CENTRAL DISC PROTRUSION. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL L4 DECOMPRESSION, L4-5 DISCECTOMY, PEDICLE SCREW FIXATION, L4-5 LATERAL MASS FUSION, REMOVAL OF OLD HARDWARE, L5-S1 LEVEL. AS PER THE OPERATIVE NOTES, ¿LOCAL AUTOLOGOUS BONE WITH MORSELIZED DENUDED SOFT TISSUE WAS USED AS A FILLING, BMP (BONE MORPHOGENIC PROTEIN) - SOAKED SPONGES WERE LAID OVER LATERAL MASS, TRANSVERSE PROCESSES OF L4-5 BILATERALLY.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155426 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC M111104AA2

    Patients

    Seq Age Sex Outcome Treatment
    1