EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received May 9, 2016 · Event occurred Mar 3, 2016
Report 3010203571-2016-00001 · MDR key 5640824
Device
Generic name
Exogen
Manufacturer
Bioventus, LlcModel number
1082020Catalog number
71034640
Lot number
10DM07835
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
31 YR · Female
- Extraskeletal ossification
- Extraskeletal ossification
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR WAS SUBMITTED ON 07 APR 2016 WITH THE INCORRECT MANUFACTURER REPORT NUMBER OF 3010203-2016-00001.
Description of Event or Problem
IT WAS REPORTED BY THE DOCTOR THAT ECTOPIC OSSIFICATION EMERGED AFTER START OF THERAPY IN THE TREATMENT AREA FOR APPROXIMATELY TWO WEEKS. THE CAUSAL OPINION IS DEEMED POSSIBLY RELATED BECAUSE THE CALLUS IS MADE AND CAUSATION CANNOT BE DENIED COMPLETELY. THE PATIENT HAS STOPPED USING THE DEVICE AND ETIDRONATE DISODIUM IS BEING ADMINISTERED. ATTEMPTS FOR ADDITIONAL FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL UP TO DATE.