BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK C/X IMPL B9.5/D4.5/L9.5

    MDR report key: 19403417 · Received May 28, 2024

    Report

    Report Number
    3013111692-2024-15428
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    November 30, 2022
    Report Date
    May 28, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532206122
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND. THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED. THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED. LATE CASE ¿ WILL BE LINKED TO CAPA-2024-95.

    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
    624237 ANK C/X IMPL B9.5/D4.5/L9.5 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 472936 07392532206122

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention