MalfunctionNDP
UNKNOWN ATIS ABUTMENT
Received Jul 14, 2026
Report 3013111692-2026-21694 · MDR key 25814343
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
UNK ATIS ABUTMENT
Lot number
UNKNOWN
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 A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO ABUTMENT FRACTURE.