BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTR

    MDR report key: 329497 · Received April 27, 2001

    Report

    Report Number
    1061897-2001-00013
    Event Type
    Injury
    Date Received
    April 27, 2001
    Date of Event
    January 30, 2001
    Report Date
    April 27, 2001
    Manufacturer
    ALTIVA CORPORATION
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    2 NTR 5/11.5 DEVICES FAILED TO OSSEOINTEGRATE. BOTH NTR 5/11.5 DEVICES IMPLANTED IN SAME PT, SAME DAY. BOTH DEVICES EXPLANTED SAME DATE IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19657 NTR DENTAL IMPLANT DZE ALTIVA CORPORATION NTR 5/11.5 (BOTH) 511-00001 (BOTH)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention