MalfunctionNDP

IMPLANT DRIVER EV (S) LONG

Received Jul 16, 2026 · Event occurred Jun 19, 2026

Report 9612468-2026-03664 · MDR key 25843709

Device

Generic name

Accessories, Implant, Dental, Endosseous

Manufacturer

Dentsply Implants (a Division Of Dentsply Ih Ab)

Catalog number

68015189

Product problems

Fracture

Patient

Male

No Clinical Signs, Symptoms or Conditions

Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER TIP BROKE OFF.