MalfunctionEGG

OT EQUATOR METAL HOUSING

Received Apr 14, 2026

Report 3004203816-2026-09928 · MDR key 24873752

Device

Generic name

Attachment, Precision, All

Manufacturer

Mis Implants Technologies Ltd.

Catalog number

OE-MH001

Lot number

W24017792

Product problems

Fracture

Patient

NA · Male

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

THE CUSTOMER REPORTED THAT THE PRODUCT BROKE.