EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received May 22, 2018 · Event occurred Apr 20, 2018
Report 3010203571-2018-00002 · MDR key 7533282
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR
- Extraskeletal ossification
- Extraskeletal ossification
Narrative
Additional Manufacturer Narrative
THERE IS NO REPORT IN THE CLINICAL LITERATURE LINKING LOW INTENSITY PULSE ULTRASOUND TO THE GENERATION OF HYPERTROPHIC OR HETEROTOPIC/ECTOPIC BONE FORMATION OR SUCH OSSIFICATIONS BEING A SIDE EFFECT OF THE TREATMENT. IT IS OF COURSE DIFFICULT TO CLEARLY DELINEATE IF HETEROTOPIC/ECTOPIC BONE FORMATION IN A FRESH TRAUMA PATIENT WAS PROMOTED BY ULTRASOUND TREATMENT OR WOULD HAVE OCCURRED NATURALLY ANYWAY. POST-MARKET SURVEILLANCE DOES NOT SHOW HETEROTOPIC BONE FORMATION TO BE REPORTED AT AN INCREASED LEVEL WHEN USING EXOGEN.
Description of Event or Problem
THE PATIENT REPORTED ON 24 APR 2018 THAT HE WAS RECOVERING FROM SURGERY THAT OCCURRED ON (B)(6) 2018 TO REMOVE EXTRA BONE GROWTH FROM AROUND THE ACHILLES IN HIS FOOT FOLLOWING COMPLETION OF EXOGEN TREATMENT FOR HIS ANKLE WHICH HAD SUCCESSFULLY HEALED. PATIENT STATED THAT EXOGEN "WORKED TOO WELL" AND CAUSED THE EXTRA BONE GROWTH. FOLLOW UP ATTEMPTS WITH THE PHYSICIAN WHO PERFORMED BOTH THE INTERNAL REDUCTION AND THE BONE GROWTH REMOVAL SURGERY WERE UNSUCCESSFUL.