MalfunctionHBS
CD HORIZON SPINAL SYSTEM
Received Jan 19, 2007 · Event occurred Dec 21, 2006
Report 1030489-2007-00017 · MDR key 812881
Device
Generic name
Rod Inserter
Manufacturer
Warsaw Orthopedic Inc.Model number
NACatalog number
7575300
Lot number
UNK
Product problems
- Device remains implanted
- Difficult to Remove
- Replace
- Malfunction
Patient
YR
- Therapy/non-surgical treatment, additional
- Surgical procedure, delayed
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE ROD INSERTER COULD NOT BE TAKEN OUT FROM THE SETSCREW DURING THE SURGERY. THE SURGEON HAD TO MAKE AN INCISION TO TAKE THE INSERTER OUT AND USED ANOTHER INSERTER TO COMPLETE THE SURGERY.