inforMED
MalfunctionNDP

DIRECT IMPRESSION COPING FOR CLOSED TRAY INTERNAL HEX.

Received Jul 14, 2026

Report 3004203816-2026-17623 · MDR key 25815874

Device

Generic name

Accessories, Implant, Dental, Endosseous

Catalog number

MD-IT100

Product problems

  • Physical Resistance/Sticking

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. PRODUCTS RETURN IS REQUESTED AND THEY 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 THERE WAS A MALFUNCTION WHERE THE CAP DOES NOT COME OFF THE TRANSFER BODY.