GUTTA-PERCHA

Description of Event or Problem

REGISTRATION FORM RECEIVED INDICATED THAT THE DEVICES WERE REMOVED DUE TO INFECTION. DEVICES EXPLANTED (B)(6) 2024. NO REPLACEMENT INDICATED ON FORM. PATIENT OUTCOME IS UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).