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)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.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.
Event or Problem Description
In this event it is reported that a atlantis abutment ti - abutment fractured leading to implant removal.The screw broke, needed to be removed.

• 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: 22056883
• Report Number: 1222802-2025-00013
• Device Sequence Number: 20622317
• Product Code: NHA
• UDI-Device Identifier: 07392532083433
• UDI-Public: 07392532083433
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: MULTIPLE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT 31010430- 0020046208
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown