MAUDE Adverse Event Report: DENTSPLY IH Inc. Atlantis Abutment Zr 00; Abutment, Implant, Dental, Endosseous

Catalog Number	35501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the atlantis abutment fractured, and the resulting fragment led to the explantation of the implant.
Additional Manufacturer Narrative
Dentsply sirona became aware of a serious injury that occurred while using the astra tech implant system.This report is for the dental atlantis abutment device.The dental implant device report was submitted separately (3013111692-2026-21820).Products return is requested and they 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.

• Brand Name: Atlantis Abutment Zr 00
• Common Device Name: Abutment, Implant, Dental, Endosseous
• Manufacturer (Section D): DENTSPLY IH Inc.; 590 lincoln street; north waltham MA 02451
• Manufacturer (Section G): DENTSPLY IH Inc.; 590 lincoln street; north waltham MA 02451
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50090515
• Report Number: 1222802-2026-00218
• Device Sequence Number: 10478906
• Product Code: NHA
• UDI-Device Identifier: 07392532083426
• UDI-Public: 07392532083426
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 35501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown