BYTE IMPRESSION KIT
Received Dec 19, 2024
Report 3014845255-2024-03155 · MDR key 20977955
Device
Generic name
General Purpose Dental Tray
Manufacturer
Shandong Huge Dental Material CorporationModel number
KITCatalog number
NA
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Deformity/ Disfigurement
- Tooth Fracture
- Deformity/ Disfigurement
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 09/17/2024.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THE IMPRESSION KIT - PUTTY CAUSED THE TOOTH TO LOOSENED UP AND WAS ABOUT TO FALL OUT.