MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) S ATLANTIS ABUTMENT TI; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 35502

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was received and investigation is currently ongoing.In case any additional information will be gained, and update will be sent.This mdr submission is a late submission.A capa has been issued.

Event Description

It was reported that a patient experienced a dental implant loss.

• Brand Name: S ATLANTIS ABUTMENT TI
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18587911
• MDR Text Key: 333849440
• Report Number: 9612468-2024-00114
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 07392532083433
• UDI-Public: 07392532083433
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: MULTIPLE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 35502
• Device Lot Number: 6727871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/19/2023
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention