InjuryLPQ
BIOVENTUS EXOGEN 4000+ SYSTEM
Received Aug 29, 2013 · Event occurred Jul 23, 2013
Report 3010203571-2013-00003 · MDR key 3423214
Device
Generic name
Exogen 4000+ System
Manufacturer
Bioventus,llcModel number
71034600Catalog number
71034600
Lot number
13EM0515
Product problems
- Off-Label Use
Patient
18 YR
- Numbness
Narrative
Description of Event or Problem
ADVERSE EVENT: NUMBNESS. WHILE USING THE DEVICE OFF LABEL TO TREAT VERTEBRATE L3 AND L5 OF THE SPINE, THE PATIENT EXPERIENCED NUMBNESS IN HER LEFT LEG.
Additional Manufacturer Narrative
(B)(4).