Unknown XiVE tool
Received Jul 28, 2026 · Event occurred Jun 24, 2026
Report 3013111692-2026-23002 · MDR key 50052352
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
UNK XiVE tool
Product problems
- Separation Failure
Patient
Unknown
- Failure of Implant
Narrative
Description of Event or Problem
It was reported that the implant was placed, but the implant driver could not be detached from the implant body, so the implant was removed.
Additional Manufacturer Narrative
Dentsply Sirona became aware of a serious injury that occurred while using the XiVE Implant System. This report is for the dental abutment device. The dental implant device report will be submitted separately. Products return is requested and they will be evaluated after receipt. In case any new or additional information will be gained from this investigation a Follow-up report will be sent. Trend is tracked and monitored.