BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCH POST TITANIUM - SZ 3

    MDR report key: 2170215 · Received July 5, 2011

    Report

    Report Number
    2523190-2011-00048
    Event Type
    Other
    Date Received
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    ELR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DENTAL OFFICE REPORTED AN ADVERSE REACTION IN A FEMALE PT WITH THE POST. SHE SAW HER PHYSICIAN AND WAS TOLD SHE WAS HAVING A NICKEL ALLERGIC REACTION. PRODUCT IS MADE BY MILTEX, THERE IS NO NICKEL IN THE POST. PRODUCT IS 90% TITANIUM, 6% ALUMINUM, AND 4% VALADIUM. DOCTOR IS NOT CONVINCED THAT THE REACTION IS FROM THE POST. POST HAD BEEN IN THE PT'S MOUTH FOR SOME TIME AS IT WAS HEALED AND CROWNED. NO PRODUCT IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCH POST TITANIUM - SZ 3 M50 - ENDODONTICS ELR INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1