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

Catalog Number	35502
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient accidentally swallowed an abutment on 07/04.No adverse health effects have been reported since the event.The patient was unable to confirm whether the abutment was expelled.
Additional Manufacturer Narrative
Product return is requested and product 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: 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 ; +1(717)845-7511
• MDR Report Key: 50090728
• Report Number: 1222802-2026-00219
• Device Sequence Number: 10271113
• Product Code: NHA
• UDI-Device Identifier: 07392532291616
• UDI-Public: 07392532291616
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 35502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• 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
• Patient Sex: Unknown