BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK IMPL B9,5 D4,5 MM/L 9,5 MM

    MDR report key: 18029858 · Received October 30, 2023

    Report

    Report Number
    3013111692-2023-59804
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 9, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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.

    Additional Manufacturer Narrative · 0

    CORRECTING UDI# FROM (B)(4) TO UNKNOWN. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 TO ANK IMPL B9,5 D4,5 MM/L 9,5 MM CATALOG # 31010228. THIS IS A FOLLOW UP REPORT FOR THIS INFORMATION.

    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
    1851548 ANK IMPL B9,5 D4,5 MM/L 9,5 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention