MalfunctionFZD
HYDROXYLAPATITE AND FLEX H/A/
Received Nov 17, 2015 · Event occurred Nov 12, 2015
Report MW5057969 · MDR key 5240054
Device
Generic name
Ear Prosthesis
Manufacturer
Medtronic XomedModel number
0590Catalog number
0590
Lot number
0208855737
Product problems
- Defective Device
- Device Operates Differently Than Expected
Patient
10/18/1
- Hearing Loss
- No Code Available
Narrative
Description of Event or Problem
DURING LEFT MIDDLE EAR EXPLORATION AND TORP REVISION, PERFORMED DUE TO WORSENING HEARING LOSS, THE EAR PROSTHESIS WAS FOUND DISPLACED AND DEFECTIVE. PHOTOGRAPHIC DOCUMENTATION WAS TAKEN OF THE DEFECT, AND IT WAS EXPLANTED.