BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK IMPL A9,5 D3,5 MM/L9,5 MM

    MDR report key: 19604854 · Received June 25, 2024

    Report

    Report Number
    3013111692-2024-18760
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    June 12, 2023
    Report Date
    July 11, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532206061
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL A9.5/D3.5/L9.5 CATALOG # 17-0543 TO ANK IMPL A9,5 D3,5 MM/L9,5 MM CATALOG # 31010208. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    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
    1157225 ANK IMPL A9,5 D3,5 MM/L9,5 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 20052719 07392532206061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 1X STAND.ABUTMENT 3101-0408.