EXOGEN ULTRASOUND BONE HEALING SYSTEM

Description of Event or Problem

IT WAS REPORTED A PATIENT PRESCRIBED THE EXOGEN SYSTEM AFTER ANKLE SURGERY, EXPERIENCED CONTINUOUS PAIN AND AN INFECTION. THE PATIENT BEGAN USING THE DEVICE IN (B)(6) OF 2020 AND AFTER AN UNKNOWN DURATION, THE PATIENT UNDERWENT A REPORTED 5 REVISIONS SURGERIES. THE PATIENT REPORTS DECREASED SENSATION AND FUNCTIONALITY OF THEIR FOOT. A FOLLOW UP WAS COMPLETED WITH THE TREATING PHYSICIAN WHO STATED THE PATIENTS' SURGERY CONSISTED OF A WOUND WASH OUT, DEBIDEMENT, AND REMOVAL OF IMPLANTED HARDWARE. THERE WERE INTRAOPERATIVE CULTURES TAKEN AND ALL TESTS CAME BACK NEGATIVE. IT IS UNKNOWN WHAT TYPE OF BACTERIA CAUSED THE INFECTION.

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. A FOLLOW UP WITH THE TREATING PHYSICIAN COULD NOT CONFIRM THE BACTERIA INVOLVED IN THE PATIENT'S INFECTION. A CLINICAL REVIEW OF THE EVENT AND FOLLOW INFORMATION RECEIVED, FOUND THERE IS NO INDICATION THE EVENT IS DIRECTLY RELATED, AS INTRAOPERATIVE CULTURES WERE NEGATIVE AND NO BACTERIA HAVE BEEN IDENTIFIED. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THIS EVENT IS INCONCLUSIVE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.