InjuryISH
RE-FLEX SHOCK
Received Apr 16, 2019
Report 3003764610-2019-00006 · MDR key 8517658
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Fall
- Injury
- Fall
- Injury
Narrative
Additional Manufacturer Narrative
FIELD SAFETY NOTICE WAS SENT TO THE CUSTOMER IN (B)(6) 2015, AFTER THE DEVICE WAS SENT OUT TO THE USER (2014). THE FIELD SAFETY NOTICE EXPLICITLY INDICATES NON-ÖSSUR COMPONENTRY NOT TO BE FITTED WITH THE ÖSSUR DEVICES AND TO TORQUE TO APPROPRIATE SETTINGS. FURTHERMORE, THE IFU EXPLICITLY INDICATES RECOMMENDS USE OF ÖSSUR ADAPTERS. NO INDICATION OF MANUFACTURING FAILURE WAS DETECTED ON THE PRODUCT DURING THE ANALYSIS. (B)(4).
Description of Event or Problem
THE PYRAMID DETACHED FROM THE FOOT AS THE PATIENT WAS WALKING. PATIENT FELL AND SUSTAINED INJURIES TO THE SHOULDER AND WRIST.