InjuryEMA
ZR-CEM
Received Jul 25, 2022 · Event occurred Jun 15, 2022
Report 2511556-2022-00003 · MDR key 15093456
Device
Generic name
Dental Cement
Manufacturer
Premier Dental Products CompanyCatalog number
3001562
Lot number
5118-13HQBSECRPISTR
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
DR. (B)(6) WAS CONTACTED BY DR. (B)(6) AND ZR-CEM WAS USED INCORRECTLY WHICH LED TO THE CROWN NOT BEING CEMENTED PROPERLY.
Description of Event or Problem
DENTIST MISUSED ZR CEM IN CEMENTING A CROWN RESULTING IN THE CROWN COMING OFF AND BECOMING SWALLOWED BY THE PATIENT.