InjuryDZE

NEOSS

Received Jun 24, 2026 · Event occurred Apr 10, 2026

Report 3017399129-2026-00082 · MDR key 25614436

Device

Generic name

Dental Implants

Manufacturer

Neoss Ab

Catalog number

21228

Lot number

15771

Product problems

Fracture

Patient

NA · Unknown

Failure of Implant

Narrative

Description of Event or Problem

IMPLANT FRACTURED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE DENTAL IMPLANT HAD FRACTURED. THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS EVALUATED. THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.