BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE - BONE GRAFT

    MDR report key: 736455 · Received July 12, 2006

    Report

    Report Number
    1030489-2006-00177
    Event Type
    Injury
    Date Received
    July 12, 2006
    Report Date
    June 12, 2006
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED THAT OTHER MANUFACTURER'S PRODUCTS WERE ALSO USED AND IT IS UNKNOWN WHAT ROLE THE INTERACTION BETWEEN THE VARIOUS COMPONENTS PLAYED IN THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. DEVICE HAS NOT BEEN EXPLANTED, SO PRODUCT EVALUATION IS NOT POSSIBLE. DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC SOFAMOR DANEK, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, MEDTRONIC SOFAMOR DANEK, OR ITS' EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, MEDTRONIC SOFAMOR DANEK, OR ITS' EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MEDTRONIC SOFAMOR DANEK, OR ITS' EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE BUILT INTO THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT. MSD OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ONE-LEVEL ANTERIOR INTERBODY FUSION AT L5-S1 USING A SYNTHES FRA SPACER/INFUSE BONE GRAFT SUPPLEMENTED WITH SYNTHESE ANTERIOR PLATE FIXATION. THE PATIENT REPORTEDLY DID WELL FOR THE FIRST FEW MONTHS, BUT BEGINNING AT TWO MONTHS POST-OP, THE SURGEON NOTED SOME RESORPTION. AT APPROXIMATELY FIVE MONTHS POST-OP, THE RESORPTION AT AN UNKNOWN LEVEL HAD PROGRESSED TO THE MID-PEDICLE LEVEL. THE PATIENT IS NOW REPORTEDLY WALKING WITH A STOOPED POSTURE. THE ANTERIOR PLATE HAS REPORTEDLY BACKED-OUT ANTERIORLY AND "PULLED OUT?. CBC, ESR, AND CRP ARE ALL UNREMARKABLE. A REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE MONTHS POST-OP VIA AN ANTERIOR APPROACH TO PACK AUTOGRAFT CHIPS INTO THE AREA OF RESORPTION, REMOVE THE ANTERIOR PLATE AND POSSIBLY INSERT PEDICLE SCREW FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE - BONE GRAFT BONE GRAFT SUBSTITUTE NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention