BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191137 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02541
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ON (B)(6) 2006, THE PATIENT UNDERWENT A C5-C7 FUSION USING RHBMP-2/ACS WITH PEEK CAGES AND TITANIUM INSTRUMENTATION. REPORTEDLY, THE PATIENT'S FOLLOW-UP SCANS FROM (B)(6) 2008 BOTH DEMONSTRATE SUBSIDENCE AT THE SITE OF PATIENTS FUSION. CONSEQUENTLY, THE CAGE ALSO MIGRATED. THE PATIENT ALSO DEVELOPED A PSEUDOARTHROSIS. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING HAVING TO UNDERGO AN ADDITIONAL SURGERY ON (B)(6) 2008, TO REMOVE THE PREVIOUS HARDWARE AND ADDRESS THE PSEUDOARTHROSIS. PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING BMP, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2006: THE PATIENT PRESENTED WITH CERVICAL SPONDYLOSIS, FORAMINAL STENOSIS, C5-C6, C6-C7, STATUS POST WORK-RELATED INJURY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY WITH FORAMINOTOMIES BILATERALLY AND OSTEOPHYTECTOMIES, C5-C6, C6-C7. ANTERIOR INTER-BODY ARTHRODESIS, C5-C6, C6-C7. PLACEMENT OF PROSTHETIC DEVICES, PEEK INTER-BODY CAGES AT C5-C6 AND C6-C7. ANTERIOR TITANIUM INSTRUMENTATION, C5 THROUGH C7. USE OF RHBMP-2 BONE MORPHOGENIC PROTEIN. INTRA-OPERATIVE SOMATOSENSORY EVOKED POTENTIAL MONITORING AND EMG MONITORING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291105 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 33 YR Required Intervention