BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, SPLINE, 10MM, 3.25

    MDR report key: 217191 · Received April 5, 1999

    Report

    Report Number
    2023141-1999-00152
    Event Type
    Injury
    Date Received
    April 5, 1999
    Report Date
    April 5, 1999
    Manufacturer
    SULZER CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT THE IMPLANTS FAILED POST RESTORATION. PT'S CONDITION IS UNK. THERE ARE 3 IMPLANTS TO BE REPORTED WITH THE FOLLOWING LOT NUMBERS: 070761, 071678, 973826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, SPLINE, 10MM, 3.25 Implant HA CYLINDER ENDOSSEOUS IMPLANTS DZE SULZER CALCITEK NA 970761

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention