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

Lot Number	10062711
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a fracture of a dental screw.

• Brand Name: Atlantis Abutm Goldshaded Ti
• Common Device Name: abutment, implant, dental, endosseous
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal vastra gotalands lan S-431 21; SW S-431 21
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50858763
• Report Number: 9612468-2026-08325
• Device Sequence Number: 9554068
• Product Code: NHA
• UDI-Device Identifier: 07392532083440
• UDI-Public: 07392532083440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Device Lot Number: 10062711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown