OSSIX BONE
Received Jul 10, 2026
Report 3027602316-2026-00027 · MDR key 25780197
Device
Generic name
Barrier, Animal Source, Intraoral
Manufacturer
Datum Dental Ltd.Catalog number
UNK DATUM DENTAL
Product problems
- Failure to Osseointegrate
Patient
NA · Unknown
- Unspecified Infection
- Inadequate Osseointegration
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FAILURE OF OSSEOINTEGRATION OF OSSIX BONE MATERIAL.
Additional Manufacturer Narrative
THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE REPORTER AND OUR EXPERIENCE IN THE INVESTIGATION OF COMPLAINTS. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. TREND IS TRACKED AND MONITORED. BASED ON THE INFORMATION GIVEN, IT IS UNLIKELY THAT A DENTSPLY SIRONA IMPLANT WAS INVOLVED IN THIS CASE.