BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK REG C/X GINGIVAF. GH 4,5

    MDR report key: 17928957 · Received October 13, 2023

    Report

    Report Number
    3013111692-2023-57882
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 11, 2023
    Report Date
    November 22, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532217333
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING ADDITIONAL TYPE OF INVESTIGATION CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. CORRECTING (B)(4)TO (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS INFORMATION. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL A9.5/D3.5/L9.5 CATALOG # 17-0543 TO ANK REG C/X GINGIVAF. GH 4.5 CATALOG # 31024016. THIS IS A FOLLOW UP REPORT FOR THIS INFORMATION. CORRECTING CONCOMITANT MEDICAL PRODUCTS FROM 31024016 TO UNKNOWN.

    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 RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551625 ANK REG C/X GINGIVAF. GH 4,5 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 486030 07392532217333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 31024016