PYRAMESH C TITANIUM MESH
Received Jan 16, 2020 · Event occurred Dec 17, 2019
Report 1030489-2020-00077 · MDR key 9597293
Device
Generic name
Mesh, Metal
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
905-800
Lot number
UNK
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3 TUMOR; AND UNDERWENT L3 CORPECTOMY AND INSERTION OF CAGE. INTRA-OP, WHEN INSERTING THE SCREW INTO THE END PLATE IN THE CAGE, THE SCREW HEAD BROKE OFF THE SHAFT. THE SHAFT REMAINS IN THE ENDPLATE, WHICH IS IMPLANTED IN THE PATIENT. THE SCREW HEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.