EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Oct 8, 2021 · Event occurred Dec 1, 2020
Report 3010203571-2021-00009 · MDR key 12598958
Device
Generic name
Exogen
Manufacturer
Bioventus LlcModel number
71034400Catalog number
71034400
Lot number
19KM14792
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
33 YR
- Unspecified Infection
- Pain
- Unspecified Infection
- Pain
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 FOOT SURGERY, EXPERIENCED CONTINUOUS PAIN AND AN INFECTION AT THE SURGICAL SITE. THE PATIENT BEGAN USING THE DEVICE IN (B)(6) OF 2020, AFTER AN UNKNOWN DURATION THE PATIENT UNDERWENT A REVISION SURGERY. DURING THE PROCEDURE THE PREVIOUSLY IMPLANTED HARDWARE WAS REMOVED AND A DEBRIDEMENT OF THE INFECTED AREA WAS COMPLETED. THE PATIENT HAS NOT REGAINED FULL FUNCTION OF THEIR FOOT FOLLOWING THE REVISION SURGERY. IT IS UNKNOWN THE TYPE OF BACTERIA THAT CAUSED THE INFECTION.