BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAPOST FIBER LUX

    MDR report key: 23617222 · Received November 21, 2025

    Report

    Report Number
    2416455-2025-00001
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 29, 2025
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    ELR
    UDI-DI
    D661PF17141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THE INITAL REPORT, ADDITIOANL INFORMATION WAS SOUGHT SINCE THE ALLERGIC REACTION WAS IDENTIFIED BY THE PATIENT AS TITANIUM DIOXIDE. SINCE COLTENE'S PRODUCT DOE NOT CONTAIN TITANIUM DIOXIDE, THE INVESTIGATION CONCLUDED THE CAUSE OF THE ALLERGIC REACTION MUST HAVE BEEN ANOTHER SOURCE OF MATERIAL USED IN THE DENTAL RESTORATION PROCEDURES BUT WAS UNABLE TO CONFIRM.

    Description of Event or Problem · 0

    ON (B)(6), COLTENE RECIEVED A REPORT FROM A PATIENT EXPALINING THAT AFTER 2 1/2 YEARS OF A BURNING SENSATION, SHE VOLUNTARILY HAD A DENTAL IMPLANT USING COLTENE'S POST ALONG WITH ANOTHER MANUFACTURER'S POST AND CORE MATERIAL REMOVED DUE TO AN ALLERGIC REACTION. THE PATIENT SAID SHE HAD EXTENSIVE ALLERGY TESTING, WHICH LED TO A DOUBLE POSITIVE REACTION TO TITANIUM DIOXIDE AND WAS INQUIRING WHETHER OR NOT COLTENE'S PRODUCT NUMBER PF1714 CONTAINED TITANIUM DIOXIDE. NO BATCH NUMBER WAS GIVEN NOR AVAILABLE. ADDITIONAL INFORMATION FOR OTHER COMPOUNDS USED IN THE PATIENT'S PROCEDURE WAS ATTEMPTED BUT NOT RECEIVED. COLTENE PRODUCT NUMBER PF1714 DOES NOT CONTAIN TITANIUM DIOXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347715 PARAPOST FIBER LUX POST, ROOT CANAL ELR COLTENE WHALEDENT INC. D661PF17141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other