BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKYLOS IMPLANT

    MDR report key: 19546226 · Received June 17, 2024

    Report

    Report Number
    3013111692-2024-17818
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    November 10, 2023
    Report Date
    July 19, 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
    CH
    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 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.

    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. REMOVING THE INFORMATION OF UNIQUE IDENTIFIER (UDI) #(B)(4). THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 TO UNKNOWN ANKYLOS IMPLANT CATALOG # UNK ANKYLOS IMPLANT. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED 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
    2337805 UNKNOWN ANKYLOS IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532206122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention