InjuryDZE

NEOSS

Received Jul 2, 2026 · Event occurred May 29, 2026

Report 3017399129-2026-00085 · MDR key 25692406

Device

Generic name

Dental Implants

Manufacturer

Neoss Ab

Catalog number

21229

Lot number

19912

Product problems

Fracture

Patient

NA · Unknown

Failure of Implant

Narrative

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.

Description of Event or Problem

IMPLANT FRACTURED.