MAUDE Adverse Event Report: Dentsply IH AB S Atlantis Abutment Ti; abutment, implant, dental, endosseous

Catalog Number	35502S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced an abutment screw fracture.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it 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.

• Brand Name: S Atlantis Abutment Ti
• Common Device Name: abutment, implant, dental, endosseous
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal S-431 21; SW S-431 21
• Manufacturer (Section G): Dentsply IH AB; aminogatan 1; molndal S-431 21; SW S-431 21
• Manufacturer Contact: dan eager ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50916487
• Report Number: 9612468-2026-08355
• Device Sequence Number: 14795021
• Product Code: NHA
• UDI-Device Identifier: 07392532291616
• UDI-Public: 07392532291616
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 35502S
• Device Lot Number: 9878453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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