PYRAMESH® IMPLANT SYSTEM
Received Sep 25, 2013 · Event occurred Aug 27, 2013
Report 1030489-2013-03979 · MDR key 3367287
Device
Generic name
Mesh, Metal
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
GXIB0801H027
Lot number
0159375W
Product problems
- Migration or Expulsion of Device
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ¿PATIENT WITH TRAUMATIC L1 BURST FRACTURE UNDERWENT A SURGERY FOR POSTERIOR FUSIONS AT TH12-L2 (L1 1 ABOVE 1 BELOW FUSION), AND A SECONDARY SURGERY FOR AN ANTERIOR FUSION AT L1. APPROXIMATELY TWO MONTHS LATER IT WAS CONFIRMED THAT THE IMPLANT WAS INCLINING. THIS CAUSED A LOAD ON SCREWS AND CAUDAL SCREWS WERE COMING OFF. THE PATIENT WAS RE-HOSPITALIZED WAS WAITING FOR A REVISION SURGERY AT THE TIME OF REPORTING.¿ NO ADDITIONAL PATIENT INFORMATION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.