Description of Event or Problem · 1
THIS 66 YEAR OLD FEMALE PRESENTED FOR ELECTIVE SURGICAL REMOVAL OF BILATERAL MANDIBULAR PROPLAST (TEFLON) JOINT IMPLANTS DUE TO FAILURE/COMPLICATIONS ASSOCIATED WITH THE IMPLANTS. THE SEVERITY OR NATURE OF THE COMPLICATIONS IS UNKNOWN TO THIS FACILITY. THE LEFT TMJ IMPLANT WAS PLACED IN 1983, AND THE RIGHT IMPLANT IN 1985 AT ANOTHER FACILITY. IT IS THIS FACILITY'S UNDERSTANDING THAT THE MANUFACTURER, VITEK, IS NO LONGER IN BUSINESS, THUS THIS REPORT IS FILED DIRECTLY WITH FDA AS PER THE MDR REPORTING GUIDELINES. GROSS DESCRIPTION REVEALS THE FOLLOWING:RIGHT TMJ IMPLANT SPECIMEN IF FRAGMENTS OF SOFT TISSUE, BONE AND FIBROUS SOFT TISSUE WITH A THIN, PLIABLE MATERIAL SIMILAR TO PLASTIC WHICH IS EMBEDDED IDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER, OTHER. CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.