MalfunctionHXY
ACUFIX
Received Apr 24, 2007 · Event occurred Mar 23, 2007
Report 1649384-2007-00022 · MDR key 954820
Device
Generic name
Threaded Screw Removal Driver
Manufacturer
Abbott SpineModel number
NACatalog number
479-1
Lot number
NI
Product problems
- Explanted
- Replace
- Tip breakage
- Device, removal of (non-implant)
Patient
YR
- Foreign body, removal of
- Surgical procedure, additional
Narrative
Description of Event or Problem
IN 2007 A PT WAS TAKEN TO THE OPERATING ROOM TO UNDERGO REVISION SURGERY DUE TO FAILURE TO FUSE. DURING THE REVISION SURGERY, THE DRIVER TIP BROKE DURING THE REMOVAL OF THE LAST 2 SCREWS. THE TIP OF THE DRIVER WAS REMOVED WITHOUT INJURY TO THE PT.
Additional Manufacturer Narrative
PRODUCT IS NOT IMPLANTABLE. REQUEST HAS BEEN MADE FOR PRODUCT. PRODUCT INVESTIGATION IS PENDING RECEIPT OF RETURNED PRODUCT.