PALACOS BONE CEMENT WITH ANTIBIOTIC

Description of Event or Problem

PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PALPITATIONS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).