MalfunctionNDP

IMPLANT DRIVER EV (L) WD GS

Received Jul 15, 2026 · Event occurred Jun 19, 2026

Report 9612468-2026-03649 · MDR key 25830629

Device

Generic name

Accessories, Implant, Dental, Endosseous

Manufacturer

Dentsply Implants (a Division Of Dentsply Ih Ab)

Catalog number

68017003

Lot number

UNK

Product problems

Fracture

Patient

Male

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK WAS BROKEN. NO PATIENT INJURY.

Additional Manufacturer Narrative

DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY.THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. IN CASE ANY NEW OR ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.