MalfunctionISH
FLEX-RUN WITH NIKE SOLE
Received May 17, 2019
Report 3003764610-2019-00007 · MDR key 8621621
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO FALL/INCIDENT NOR INJURY OCCURRED DUE TO THE REPORTED FAILURE. GIVEN THE INTENDED USE (RUNNING, SPORTS ACTIVITIES) OF THE PRODUCT, THERE IS A RISK FOR ISSUE LEADING TO INJURY WHEN FAILURE WOULD OCCUR DURING USE. THEREFORE WE SEND IN THIS VIGILANCE REPORT. OSSUR IS HOWEVER NOT AWARE THAT THE DESCRIBED FAILURE TYPE FOR THIS PROSTHETIC FOOT EVER LED TO INJURY. (B)(4).
Description of Event or Problem
DEVICE BROKE SUDDENLY DURING TRAINING. NO INJURIES OCCURED.