InjuryDZE
PrimeTaper EV Ø4.8 x 9mm OS
Received Jul 31, 2026 · Event occurred Feb 1, 2026
Report 9612468-2026-03909 · MDR key 50099599
Device
Generic name
Implant, Endosseous, Root-form
Manufacturer
Dentsply Implants (a Division Of Dentsply Ih Ab)Catalog number
68011105
Product problems
- Failure to Osseointegrate
Patient
Not reported
- Failure of Implant
- Inflammation
- Osteolysis
Narrative
Description of Event or Problem
It was reported that a patient experienced dental implant loss associated with progressive bone loss due to peri-implantitis at site 23.
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.