BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190284 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02520
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    September 26, 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 THE PATIENT UNDERWENT A C4-C6 FUSION INVOLVING RHBMP-2/ACS. SURGEON UTILIZED A POSTERIOR APPROACH, USED A PEEK SPACER, AND MIXED RHBMP-2/ACS WITH ALLOGRAFT AND AUTOGRAFT. PATIENT WAS DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT INCLUDING AN ADDITIONAL SURGERY ON (B)(6)-2010. PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, 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) 2010: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: PSEUDARTHROSIS C4-5, C5-6 FROM PREVIOUS ANTERIOR CERVICAL SURGERY AND UNDERWENT PROCEDURE: POSTERIOR CERVICAL FUSION C4-5, C5-6. INTERNAL FIXATION USING LATERAL MASS SCREWS. ALLOGRAFT. AUTOGRAFT FOR FUSION. CONTINOUS NEURO-ELECTROPHYSIOLOGICAL MONITORING DURING THE ENTIRE CASE. USE OF THE STEALTH WITH O-ARM NAVIGATION. PER OP-NOTES:....ONCE THESE WERE DONE, A SERIES OF SIX SCREWS WERE USED, 3.5 X 10, ON THE LEFT SIDE AND A 4.0 X 12 ON THE LEFT. ON THE RIGHT SIDE, 4.0X10, 4.0X12 AND 3.5X10 WERE USED. ONCE THIS WAS DONE, THE 3.2 ROD WAS CUT AND USED TO ATTACH TO THE POLYAXIAL HEADS. ONCE THIS WAS DONE, THEY WERE ATTACHED. NO COMPRESSION WAS DONE AND THEY WERE ESTABLISHED IN SITU. DECORTICATION WAS DONE; SPINOUS PROCESSES OF C4, C5 AND C6 WERE TAKEN DOWN AND AFTER DECORTICATION WAS DONE, THIS WAS USED TO HELP AUGMENT THE FUSION AS WELL AS RHBMP-2/ ACS. PRIOR TO DOING THIS, COPIOUS IRRIGATION WAS DONE. AND HEMOVAC DRAIN WAS LEFT DEEP IN THE WOUND. X-RAYS WERE TAKEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289590 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110915AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other| R