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

Catalog Number	35503
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.This report is about the same incident as report number 3013111692-2024-03717.Since both items may have contributed to the event a report was sent for each of them.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.

• Brand Name: S ATLANTIS ABUTM GOLDSHADED 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18657913
• Report Number: 1222802-2024-00001
• Device Sequence Number: 12587245
• Product Code: NHA
• UDI-Device Identifier: 07392532083440
• UDI-Public: 07392532083440
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/07/2024

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: 35503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AZENTO 0014469999 .
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown