OtherOSH
LANX SPINAL FIXATION SYSTEM
Received Jul 26, 2013 · Event occurred Jun 21, 2013
Report 3004485144-2013-00027 · MDR key 3254171
Device
Product problems
- Break
Patient
65 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY WAS PERFORMED TO ADDRESS A BROKEN PEDICLE SCREW.
Additional Manufacturer Narrative
REVIEW OF THE ASSOCIATED DHR FOUND NO DEVICE NONCONFORMITIES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PRODUCT LABELING IDENTIFIES IMPLANT BREAKAGE OR FAILURE AS POSSIBLE COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.