MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) PRIMETAPER EV Ø4.2 X 8MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68011097
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377); Implant Pain (4561)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the additional information that was provided from a follow up with the customer.Product was received.Health effect - clinical code added 1930 and 4561.Medical device problem code updated to 2408.

• Brand Name: PRIMETAPER EV Ø4.2 X 8MM OS
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22880500
• Report Number: 9612468-2025-01514
• Device Sequence Number: 9313785
• Product Code: DZE
• UDI-Device Identifier: 07392532258671
• UDI-Public: 07392532258671
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 68011097
• Device Lot Number: 528105
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/23/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown