CX SPECTRA ST REF LV SYR A3

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT CX SPECTRA ST REF LV SYR A3 THAT WAS USED IN TREATMENT, SOME FILLINGS IN A FEW PATIENTS HAVE SOFTENED AND CAN BE REMOVED WITH A HARD INSTRUMENT. WHILE OTHER FILLINGS WITH THE SAME MATERIAL REMAIN UNAFFECTED. FURTHER INFORMATION REQUESTED.

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 AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. NO RETURNED PRODUCT, NO LOT AVAILABLE, NO INVESTIGATION IN QC POSSIBLE.