Cercon yo ML A3 disk 98 18
Received Mar 31, 2026 · Event occurred Mar 3, 2026
Report 9681199-2026-00001 · MDR key 24742099
Device
Product problems
- Break
Patient
Unknown
- Laceration(s)
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A CERCON YO ML A3 DISK 98 18 USED IN TREATMENT, FRACTURE OF THE BRIDGE 10 DAYS AFTER INTEGRATION. THE PATIENT ALSO EXPERIENCED A CUT ON THEIR TONGUE.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.