BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3481119 · Received November 21, 2013

    Report

    Report Number
    1030489-2013-04611
    Event Type
    Injury
    Date Received
    November 21, 2013
    Report Date
    January 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL SPINAL FUSION AT L5-S1 WITH CAGE INSTRUMENTATION, RIGHT ILIAC CREST BONE GRAFT AND RHBMP-2/ACS ON (B)(6) 2010. PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE, FORAMINAL SPINAL STENOSIS, AND INSTABILITY AT L5-S1. PATIENT HAS HAD INCAPACITATING BACK AND LEG PAIN RELATED TO SEVERE FORAMINAL STENOSIS AND DEGENERATIVE DISC AT L5-S1. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. POSTEROLATERAL SPINAL FUSION, L5-S1; 2. TRANSFORAMINAL LUMBAR INTERBODY FUSION, L5-S1; 3. PEDICLE SCREW INSTRUMENTATION, L5-S1; 4. CAGE INSTRUMENTATION, L5-S1; 5. RIGHT ILIAC CREST BONE GRAFT AND USE OF RHBMP-2/ACS. A LARGE RHBMP-2/ACS WAS SPLIT TRANSVERSELY, FILLED WITH ILIAC CREST AUTO GRAFT AND ROLLED ONTO ITSELF. THE RHBMP-2/ACS, ILIAC CREST AND LOCAL BONE COMPOSITE WAS PACKED OVER THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE A POSTEROLATERAL ARTHRODESIS. THIS WAS SUPPLEMENTED WITH MASTERGRAFT MATRIX. THIS WAS LAID OVER THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE A POSTEROLATERAL ARTHRODESIS FROM L5-S1. NO COMPLICATIONS WERE REPORTED. (B)(6) 2010: PATIENT UNDERWENT A CT OF THE ABDOMEN DUE TO COMPLAINTS OF ABDOMINAL PAIN. STUDY FOUND NO ABDOMINAL ABNORMALITIES. THE PATIENT'S POST OPERATIVE PERIOD WAS MARKED BY SEVERE, PAINFUL, AND DEBILITATING COMPLICATIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, THE NEED FOR ADDITIONAL SURGERY, PAINFUL MEDICAL TREATMENT, EXTREME PAIN, NERVE DAMAGE, NERVE IMPINGEMENT, AND SEVERE EXUBERANT ECTOPIC BONE FORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON, ON AN UNKNOWN DATE PATIENT UNDERWENT BILATERAL L5-S1 LAMINOTOMY, FORAMINOTOMY, MEDIAL FACETECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605627 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 00069 YR Required Intervention