BYTE IMPRESSION KIT

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT WAS REMOVING THE TOP TRAY OF THE IMPRESSION KIT-PUTTY AND IT BROKE OFF THE BONDING ON THE FRONT TOOTH. THE PATIENT'S DENTAL PROVIDER SENT A LETTER OF RECOMMENDATION (LOR) TO CEASE TREATMENT DUE TO THE FRACTURED TEETH AND POSSIBLE FURTHER DAMAGE.

Additional Manufacturer Narrative

SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21CFR 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.