BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3200869 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02856
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 1, 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)(6). (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.

    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 UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED. POST-OPERATIVELY, IMAGES WERE REVIEWED ON (B)(6) 2009. FINDINGS: OBTAINED AND REVIEWED, 4+ VIEWS OF THE LUMBAR SPINE DEMONSTRATE INTERBODY GRAFT WITH ANTERIOR FIXATION AT L4-5 AND L5-S1. THE L4-5 FUSION ANTERIORLY APPEARS FAIRLY ROBUST. THERE APPEARS TO BE A RADIOLUCENT LINE, ESPECIALLY ON THE OBLIQUES AT THE L5-S1 LEVEL WHICH WE ARE ABLE TO SEE TODAY WHICH MAKES ME SUSPICIOUS FOR A PSEUDOARTHROSIS OR INCOMPLETE FUSION AT THE L5-S1 LEVEL. CT SCAN FINDINGS: WE DID REVIEW A CT SCAN TODAY AS WELL AS WHICH DEMONSTRATES CALCIFICATION IN THE SPINAL CANAL AT THE L4-5 AND THE L5-S1 LEVEL AS WELL AND POSTERIOR TO THE L5 VERTEBRA. THIS APPEARS TO BE CALCIFICATION IN BONE FORMATION LEADING FROM THE DISC SPACE OUT INTO THE POSTERIOR CANAL. THE L4-5 FUSION IS MOST LIKELY FUSED, AND I WOULD SAY THAT THE L5-S1 LEVEL IS SUSPICIOUS AND POSSIBLY NOT FUSED. THIS MATERIAL IS IN THE REGION DECOMPRESSING THE EXITING L4 NERVE ROOT AS WELL AS THE L5 TRAVERSING ROOT DOWN TOWARDS S1 ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301599 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