OPTIPAC 80 REFOBACIN BONE CEMENT R

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. CLINICAL ADVERSE EVENT RECEIVED FOR JAK2 ESSENTIAL THROMBOCYTHEMIA. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED), READMITTED TO HOSPITAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).