OPTIMESH
Received Sep 5, 2007 · Event occurred Aug 13, 2007
Report 2135156-2007-00003 · MDR key 908737
Device
Product problems
- Device remains implanted
Patient
27 YR
- Bone Fracture(s)
- Neurological Deficit/Dysfunction
- Disability
- Therapy/non-surgical treatment, additional
- Surgical procedure, additional
- Hospitalization required
Narrative
Additional Manufacturer Narrative
TO DATE, THE COMPANY HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. ADD'L LOT# S07003.
Description of Event or Problem
PT WAS BEING TREATED FOR TRAUMATIC FRACTURES OF T7 AND T8 DUE TO A CAR ACCIDENT 6 MONTHS PRIOR. SURGERY WAS UNEVENTFUL: OPTIMESH AND BONE GRAFT PLACED AT EACH LEVEL. NEURAL MONITORING USED THROUGHOUT. PT AWOKE IN RECOVERY ROOM REPORTING MOTOR/SENSORY LOSS. POST-OP CT WAS TAKEN WHICH SHOWED POSTERIOR WALL FRACTURE AND PEDICLE FRACTURE AT T7. LAMINECTOMY WAS PERFORMED, T6-T9. SURGERY ON FOLLOWING DAY INCLUDED PLACEMENT OF PEDICLE SCREW CONSTRUCT FROM T6-T9 AND AN ANTERIOR DECOMPRESSION.