BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830007 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02099
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    May 11, 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 THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS, L2-3, AND L3-4. SHE UNDERWENT FOLLOWING PROCEDURES: HARDWARE REMOVAL, EXPLORE FUSION L2-3, L3-4. LUMBAR LAMINOTOMY AND EXPLORATION, LEFT L4 NERVE ROOT. REVISION SPINAL FUSION WITH INSTRUMENTATION AND BONE MORPHOGENIC PROTEIN AND GRAFT L2 TO L4. AS PER OPERATIVE NOTES, ¿THE POSTEROLATERAL ELEMENTS WERE DECORTICATED WITH A HIGH-SPEED DRILL. GRAFT AND BONE MORPHOGENIC PROTEIN WAS PACKED IN THE POSTEROLATERAL ELEMENTS. 7 X 40 PEDICLE SCREWS WERE PLACED IN THE PEDICLES OF L2, 3, AND 4 ON THE RIGHT AND L2 AND 3 ON THE LEFT. GELFOAM WAS PLACED IN THE PEDICLE HOLE OF L4 ON THE LEFT. A TRIPLE HALF-SLOT PLATE WAS CHOSEN AND SLIGHTLY BENT ON THE RIGHT SIDE AND A DOUBLE HALF SLOT WAS CHOSEN AND BENT ON THE LEFT SIDE.¿ 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 M110610AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other