BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK REG /X ABUT GH 1,5 A 0

    MDR report key: 20663848 · Received November 12, 2024

    Report

    Report Number
    3013111692-2024-34083
    Event Type
    Injury
    Date Received
    November 12, 2024
    Report Date
    May 30, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NHA
    UDI-DI
    07392532217401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THIS EVENT IS ABOUT A FRACTURED ABUTMENT AND NOT A FRACTURED IMPLANT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDING UDI # (B)(4).THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDING COMPONENT CODE 4755 THAT WAS MISSED IN THE INITIAL SUBMITTED REPORT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM UNKNOWN ANKYLOS IMPLANT CATALOG # UNK ANKYLOS IMPLANT TO ANK REG /X ABUT GH 1,5 A 0 CATALOG # 31024120. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING PRODUCT CODE FROM DZE TO NHA CORRECTING COMMON DEVICE NAME FROM IMPLANT, ENDOSSEOUS, ROOT-FORM TO ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS. THIS IS A FOLLOW UP REPORT FOR THE CORRECTIONS TO THIS INFORMATION.

    Additional Manufacturer Narrative · 0

    B5. HAS BEEN CORRECTED IN THIS REPORT.

    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 ABUTMENT BREAKAGE. CUSTOMER RECEIVED REPAIR TOOLS AND MANUAL. THERE IS NO FURTHER INFORMATION WHICH INDICATES THAT THE REPAIR ATTEMPT FAILED.

    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
    1542318 ANK REG /X ABUT GH 1,5 A 0 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532217401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention