InjuryLOF
EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Apr 8, 2016 · Event occurred Mar 3, 2016
Report 3009595577-2016-00002 · MDR key 5565124
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
31 YR
- Extraskeletal ossification
- Extraskeletal ossification
Narrative
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.