MalfunctionNDP

IMPLANT DRIVER EV (S) LONG

Received Jul 15, 2026

Report 9612468-2026-03639 · MDR key 25825515

Device

Generic name

Accessories, Implant, Dental, Endosseous

Manufacturer

Dentsply Implants (a Division Of Dentsply Ih Ab)

Catalog number

68015189

Lot number

1875972

Product problems

Fracture

Patient

NA · Unknown

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. 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.

Description of Event or Problem

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