MAUDE Adverse Event Report: DENTSPLY IH INC. 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.Dhr review for the product(s) related to this complaint has been completed and did not reveal any anomalies.The product(s) related to this complaint has been requested to be returned from the customer three separate times, however, the item(s) has not been returned.This complaint cannot be fully investigated without the product(s).Per accepted dentsply sirona implants procedures this complaint shall be closed.If at any time the product(s) is returned to dentsply sirona implants, the complaint file shall be re-opened and a full investigation shall be completed.
Event or Problem Description
In this event it is reported that a atlantis abutment ti a dentist informed about the screw fractured when delivering atlantis abutment needs a replacement screw.It is indicating that fracture screw was not removed from implant.Implant is not loadable.Doctor decided to leave screw fragment inside implant and not load it.Implant was not removed.Reopened case to change it from non- serious to serious.

• Brand Name: 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: 22148842
• Report Number: 1222802-2025-00019
• Device Sequence Number: 20915097
• Product Code: NHA
• UDI-Device Identifier: 07392532083433
• UDI-Public: 07392532083433
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: MULTIPLE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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
• Device Catalogue Number: 35502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown