InjuryDZE
PrimeTaper EV Ø4.8 x 8mm OS
Received Jul 31, 2026 · Event occurred Jun 23, 2026
Report 9612468-2026-03906 · MDR key 50096565
Device
Generic name
Implant, Endosseous, Root-form
Manufacturer
Dentsply Implants (a Division Of Dentsply Ih Ab)Catalog number
68011104
Lot number
539112
Product problems
- Failure to Osseointegrate
Patient
Not reported
- Failure of Implant
- Implant Pain
Narrative
Description of Event or Problem
It was reported that the patient experienced dental implant loss and pain.
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.