EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Oct 8, 2021 · Event occurred Apr 1, 2020
Report 3010203571-2021-00010 · MDR key 12599230
Device
Generic name
Exogen
Manufacturer
Bioventus LlcModel number
71034400Catalog number
71034400
Lot number
19AM13420
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
52 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. A FOLLOW UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED.
Description of Event or Problem
IT WAS REPORTED A PATIENT PRESCRIBED THE EXOGEN SYSTEM AFTER ANKLE SURGERY, EXPERIENCED AN INFECTION IN HER LEG. THE PATIENT BEGAN USING THE DEVICE IN APRIL OF 2020, AFTER AN UNKNOWN DURATION THE PATIENT WAS REPORTED TO HAVE HAD ANOTHER SURGERY. AFTER THE SECOND SURGERY IT WAS REPORTED THE PATIENT CONTRACTED A BLOOD INFECTION. THE PATIENT IS REPORTED TO STILL BE ON ANTIBIOTICS AND HAS NOT FULLY RECOVERED. IT IS UNKNOWN WHAT TYPE OF BACTERIA CAUSED THE INFECTION.