BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER DENTAL

    MDR report key: 2061332 · Received April 11, 2011

    Report

    Report Number
    MW5020276
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 12, 2011
    Report Date
    April 8, 2011
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ZIMMER DENTAL IMPLANT SURGICALLY IMPLANTED (B)(6) 2006 FOR TOOTH #30 IN PT (B)(6) BY DR. (B)(6). PT HAD CONTINUING PROBLEMS WITH THE IMPLANT RESULTING IN BONE GRAFTS, REMOVAL AND REPLACEMENT OF CROWN, AND EVENTUAL TOTAL FAILURE, WHEN IMPLANT CAME AROUND (B)(6) 2011. WHEN IMPLANT WAS GIVEN TO DR. (B)(6), HE EXAMINED IT AND TOLD US THAT IT WAS "CLEARLY DEFECTIVE." HE TOOK THE IMPLANT TO RETURN TO THE MFR. HE SUBSEQUENTLY TOLD US THAT HE HAD RETURNED IT TO ZIMMER AND WAS WAITING FOR A RESPONSE FROM THEM ABOUT IT. HE SAID THAT THE DEFECT COULD HAVE RESULTED IN BACTERIA GETTING INTO THE BONE AND CAUSING INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER DENTAL DENTAL IMPLANT DZE TSV 3.7MM X 8MM 0512287

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other