MAUDE Adverse Event Report: DENTSPLY IH INC. S ATLANTIS ABUTMENT TI; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	35502
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a s atlantis abutment became stuck in a dental implant, resulting implant loss.
Additional Manufacturer Narrative
Investigation revealed that the customer ordered the wrong interface on the original order, they ordered a ankylos welded type screw by mistake and this is why it became stuck in the dental implant.

• Brand Name: S ATLANTIS ABUTMENT TI
• 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 ; 7178457511
• MDR Report Key: 22814006
• Report Number: 1222802-2025-00021
• Device Sequence Number: 18395688
• Product Code: NHA
• UDI-Device Identifier: 07392532083433
• UDI-Public: 07392532083433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: MULTIPLE
• 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): 08/15/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 35502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown