HANDPIECE IMPLANT DRIVER (SHORT)

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL DOES NOT KNOW THE LOT NUMBER, THEY ONLY KNOW IT WAS A SHORT DRIVER, THEREFORE, INFORMATION RELATED TO THE PRODUCT INFORMATION IS UNKNOWN. THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE INVESTIGATION IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT A 56-YEAR-OLD FEMALE PATIENT UNDERWENT IMPLANT PLACEMENT ON TOOTH NUMBER 29 ON (B)(6) 2026. INSTRUMENT FRACTURE AND DEFORMATION AS WELL AS A FIT ISSUE WITH THE IMPLANT AND OTHER COMPONENTS WERE REPORTED, IT WAS STATED THAT THE HEAD OF THE IMPLANT DIVER BROKE, FRACTURING AT THE HEAD INSIDE THE IMPLANT DURING PLACEMENT. IT WAS STATED THAT THE IMPLANT ITSELF WAS NOT DEFECTIVE UPON PLACEMENT BUT BY THIS POINT IT WAS NO LONGER RESTORABLE AND HAD TO BE REMOVED, IT WAS REMOVED ON THE SAME DAY, (B)(6) 2026.PER THE REPORT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR PERMANENT INJURY AND DID NOT REQUIRE ADDITIONAL PROCEDURES. THE IMPLANT WAS REPLACED WITH A SIMILAR DEVICE. THE PATIENT'S BONE QUALITY WAS REPORTED AS TYPE III WITH EXCELLENT ORAL HYGIENE. EVENT WAS REPORTED TO THE DENTAL OFFICE LOCATED IN (B)(6).