MalfunctionNDP

IMPLANT DRIVER EV (XS) LONG

Received Jul 15, 2026

Report 9612468-2026-03637 · MDR key 25825431

Device

Generic name

Accessories, Implant, Dental, Endosseous

Manufacturer

Dentsply Implants (a Division Of Dentsply Ih Ab)

Catalog number

68015187

Lot number

1752252

Product problems

Fracture

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE.

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 PRODUCT 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.