PYRAMESH
Received Mar 20, 2013 · Event occurred Feb 19, 2013
Report 1030489-2013-00787 · MDR key 3012711
Device
Manufacturer
Medtronic Sofamor Danek Instrument ManufacturingModel number
NACatalog number
G905H166
Lot number
0036937W
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
00063 YR
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE AT THORACIC 9-L2, THORACIC 9(HOOK)-THORACIC 10,THORACIC 11(PEDICLE SCREWS)-LUMBAR 1, LUMBAR 2(PEDICLE SCREWS), AND A CORPECTOMY AT THORACIC 12. IT WAS REPORTED THAT DURING CAGE PLACEMENT, THE CAGE BROKE THE CRANIAL ENDPLATE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.