MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) ATLANTIS ABUTM GOLDSHADED TI; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	35503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.
Event or Problem Description
It was reported that a patient experienced a dental abutment fracture.

• Brand Name: ATLANTIS ABUTM GOLDSHADED TI
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23921256
• Report Number: 9612468-2025-02706
• Device Sequence Number: 9013198
• Product Code: NHA
• UDI-Device Identifier: 07392532291630
• UDI-Public: 07392532291630
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 35503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANKYLOS IMPLANT A8, 31010405, 466427.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown