POLY F INTRO 70G/40ML

Additional Manufacturer Narrative

SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT POLY F INTRO 70G/40ML USED IN TREATMENT OF A PATIENT ALLEGEDLY THE CROWN DE-BONDED AND THIS CAUSED TOOTH DISCOMFORT THAT INCLUDED SENSITIVITY AND PAIN TO HOT AND COLD STIMULI. THE CROWN WAS RE-CEMENTED WHICH RESOLVED PATIENT'S SYMPTOMS.

Additional Manufacturer Narrative

RETAIN A CUSTOMER SAMPLE WAS NOT SENT. THE SETTING BEHAVIOR OF THE RETAINED SAMPLE WAS TESTED AND IS WITHIN SPECIFICATION. THE MATERIAL HARDENS. THE RETAIN PRODUCT CAN BE MIXED AND PROCESSED AS USUAL. THE COLOR OF THE RETAIN PRODUCT IS LIGHT YELLOW AND THE DRY CAPSULE IS ORANGE. THIS MEANS THAT THE MATERIAL IS DRY. THE COMPLAINT CANNOT BE CONFIRMED. DHR THE DHR OF THE COMPLAINED BATCH WAS CHECKED. THERE WERE NO ABNORMALITIES IN THE DHR.