BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABUTMENT: SHLD, 2MM, OMINLOC, 3.25

    MDR report key: 38864 · Received September 20, 1996

    Report

    Report Number
    2023141-1996-00060
    Event Type
    Death
    Date Received
    September 20, 1996
    Date of Event
    August 23, 1996
    Report Date
    August 22, 1996
    Manufacturer
    CALCITEK, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    D6: MD REPORTED (1) 0612 BUT RETURNED (2) 0612. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORIES OF THE SUBJECT PRODUCTS COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE MD'S OFFICE.

    Description of Event or Problem · 1

    AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABUTMENT: SHLD, 2MM, OMINLOC, 3.25 Implant SCREW RETAINED DENTAL ABUTMENT DZE CALCITEK, INC. NA (2)UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention