MalfunctionNDP

IMPLANT DRIVER EV (XL) LONG

Received Jul 14, 2026 · Event occurred May 18, 2026

Report 9612468-2026-03599 · MDR key 25813244

Device

Generic name

Accessories, Implant, Dental, Endosseous

Manufacturer

Dentsply Implants (a Division Of Dentsply Ih Ab)

Catalog number

68015195

Product problems

Insufficient Device Problem Information

Patient

NA · Unknown

Insufficient Information

Narrative

Additional Manufacturer Narrative

DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION WITH INSUFFICIENT INFORMATION. IT IS UNCLEAR WHETHER THE MALFUNCTION COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY.PRODUCT RETURN AND ADDITIONAL INFORMATION IS REQUESTED AND WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED 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.