PYRAMESH IMPLANT SYSTEM
Received May 24, 2018 · Event occurred Apr 26, 2018
Report 1030489-2018-00740 · MDR key 7543446
Device
Generic name
Mesh, Metal
Manufacturer
Medtronic Sofamor DanekModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Migration or Expulsion of Device
- Migration or Expulsion of Device
Patient
Not reported
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
TYPE OF PROCEDURE OR TECHNIQUE USED: TES(POSTERIOR FUSION PERFORMED AT 2A2B) PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE : METASTASIS LEVEL: L1 IT WAS REPORTED THAT ON (B)(6) 2018, POST-OP, THE CAGE WHICH WAS PLACED AT L1 WAS SINKING ON THE SUPERIOR END PLATE. PATIENT HAD PROLONGED HOSPITALIZATION DUE TO THE PLANNED REOPERATION.