DeathEZX
PYRAMESH C TITANIUM MESH
Received Mar 27, 2012 · Event occurred Oct 14, 2011
Report 1030489-2012-00361 · MDR key 2505689
Device
Generic name
Mesh, Metal
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
905-137
Lot number
0073552W
Product problems
- Insufficient Device Problem Information
Patient
00055 YR
- Death
- Edema
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TITANIUM ANTERIOR CERVICAL PLATE AND TITANIUM MESH INTERBODY DEVICE. POST-OP DAY ONE THE PATIENT REPORTEDLY HAD LARYNGEAL EDEMA AND UNDERWENT ADDITIONAL SURGERY TO RELIEVE THE SYMPTOMS. POST-OP DAY, TWO THE PATIENT REPORTEDLY DIED DUE TO CEREBRAL EDEMA.
Additional Manufacturer Narrative
(B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.