MAUDE Adverse Event Report: Dentsply IH AB PrimeTaper EV Ø4.2 x 8mm OS; implant, endosseous, root-form

Catalog Number	68011097
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss; implant failed after 1 month - lack of osseointegration with infection and progressive bone loss.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it 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.

• Brand Name: PrimeTaper EV Ø4.2 x 8mm OS
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal 431 2 1; SW 431 21
• Manufacturer (Section G): Dentsply IH AB; aminogatan 1; molndal 431 2 1; SW 431 21
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50437834
• Report Number: 9612468-2026-08043
• Device Sequence Number: 9176681
• Product Code: DZE
• UDI-Device Identifier: 07392532276705
• UDI-Public: 07392532276705
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: Other
• Device Catalogue Number: 68011097
• Device Lot Number: 529401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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