inforMED
MalfunctionNDP

FRAGMENT DRILL Ø0.8

Received Jul 16, 2026

Report 3013111692-2026-22041 · MDR key 25837971

Device

Generic name

Accessories, Implant, Dental, Endosseous

Catalog number

25858

Product problems

  • Fracture

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE TOOL FRACTURED.

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. PRODUCT RETURN IS REQUESTED AND 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. THE FRACTURED ABUTMENT FOR WHICH THIS TOOL WAS USED WAS REPORTED WITH REPORT NUMBER 3013111692-2026-06220.