PYRAMESH IMPLANT SYSTEM
Received Nov 30, 2015
Report 1030489-2015-03187 · MDR key 5255891
Device
Generic name
Mesh, Metal
Manufacturer
Medtronic Sofamor DanekModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
00062 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
LITERATURE CITATION : IZUMI T., YAMAZAKI A., MIZOUCHI T., TASHI H., SANO A. "LOCAL ALIGNMENT BY PYRAMESH-LT CAGE USED FOR SINGLE INTERVERTEBRAL PLIF." MEAN AGE: 62.4 YEARS. GENDER: 154 MALE AND 100 FEMALE. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED IN AN ABSTRACT THAT TOTAL OF 254 PATIENTS UNDERWENT SINGLE LEVEL POSTERIOR LUMBAR INTERBODY FUSION (PLIF) USING CAGE IN THE PERIOD BETWEEN 2004 - 2008. AS POST-OP COMPLICATIONS, 7 NONUNIONS WERE OBSERVED.