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

Catalog Number	68011104
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced periimplantitis and a dental implant loss.
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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the additional information that was provided from a follow up with the customer.H6 updated: health effect - clinical code: add code 1930.

• Brand Name: PRIMETAPER EV Ø4.8 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: 22887995
• Report Number: 9612468-2025-01518
• Device Sequence Number: 4915580
• Product Code: DZE
• UDI-Device Identifier: 07392532258749
• UDI-Public: 07392532258749
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K210610
• 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: 68011104
• Device Lot Number: 515319
• 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: 09/03/2025
• Initial Report FDA Received Date: 08/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALING ABUTMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown