BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK REG /X ABUT GH 1,5 A 0

    MDR report key: 19994279 · Received August 15, 2024

    Report

    Report Number
    1222802-2024-00009
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 15, 2024
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532217401
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT WAS RECEIVED. PRODUCT INVESTIGATION NOT YET DONE. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PER DOCTOR, ABUTMENT AND SCREW FRACTURED, IMPLANT NOT LOADABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177945 ANK REG /X ABUT GH 1,5 A 0 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. B140005155 07392532217401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention