InjuryDZE
PrimeTaper EV Ø4.2 x 9mm OS
Received Jul 31, 2026 · Event occurred Jun 16, 2026
Report 9612468-2026-03903 · MDR key 50096506
Device
Generic name
Implant, Endosseous, Root-form
Manufacturer
Dentsply Implants (a Division Of Dentsply Ih Ab)Catalog number
68011098
Lot number
543393
Product problems
- Failure to Osseointegrate
Patient
Not reported
- Failure of Implant
Narrative
Description of Event or Problem
It was reported that a patient experienced 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.