HEALIX ADVANCE SP ANCHOR (MITEK

Description of Event or Problem

PARAMETRICS MEDICAL DISTRIBUTED TWO DERMIS ON DEMAND ALLOGRAFTS ((B)(4) SERIAL NUMBERS (B)(4)) TO THE CENTER FOR AMBULATORY SURGERY CENTER ON (B)(6) 2020. BOTH ALLOGRAFTS WERE IMPLANTED DURING A SHOULDER REPAIR BY DR. (B)(6) ON (B)(6) 2020. THE FOLLOWING WERE ALSO IMPLANTED DURING THE PROCEDURE: Y-KNOT SUTURE ANCHORS (LINVATEC) X 3 AND HEALIX ADVANCE SP ANCHORS (MITEK 222425, LOT 6L19804) X2. ON (B)(6) 2020 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO REMOVE ALL THE HARDWARE DUE TO AN INFECTION. THE INCISION WAS OPEN AND RED, AND THE TISSUE WAS INFLAMED DEEP DOWN TO THE REPAIR AND BONE. ALL HARDWARE WAS REMOVED, MINUS THE TIP OF THE HEALIX ADVANCE SP DILATOR TIPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO CONTINUE ANTIBIOTICS OVERNIGHT. PARAMETRICS MEDICAL RECEIVED THE COMPLAINT NOTIFICATION ON 07-17-2020 AND NOTIFIED (B)(6) ON 07-20-2020. AT THIS TIME NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR ALLOGRAFTS COULD BE OBTAINED FOLLOWING MULTIPLE ATTEMPTS.