PYRAMESH IMPLANT SYSTEM

Additional Manufacturer Narrative

(B)(4). 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

Description of Event or Problem

(B)(6) 2006, THE PATIENT UNDERWENT THORACOTOMY FOR L1 CORPECTOMY WITH FUSION OF T12-L1 USING PYRAMESH AND RHBMP-2/ACS. ON POD 3, X-RAYS APPEARED TO INDICATE ¿THE MIDDLE GRAFT MOVING OUT OF THE SEAT THAT WAS CREATED FOR IT IN THE T12-L2 VERTEBRAL BODIES.¿ (B)(6) 2006 ,THE PATIENT UNDERWENT REVISION SURGERY TO ADDRESS HARDWARE MIGRATION. SURGERY CONSISTED OF DECOMPRESSIVE LAMINECTOMY, T11 THROUGH L3 WITH MICRODISSECTION, HARVEST OF LOCAL BONE, PLACEMENT OF PRYAMESH CAGE, POSTEROLATERAL FUSION WITH RODS AND SCREWS, T11-L3. (B)(6) 2006-CT SCAN INDICATED ¿ORTHOPEDIC DEVICES APPEAR IN GOOD POSITION. ONE OF THE SCREWS IN THE ANTERIOR ASPECT OF T12 EXTENDS TO THE RIGHT DIAPHRAGMATIC CRURA, BUT NO SIGNIFICANT HEMATOMA IS SEEN IN THIS LOCATION. SMALL HEMATOMA IN THE LEFT PSOAS MUSCLE AT THE L2 LEVEL ARISING FROM THE BONE SCREW THAT WAS PLACED FROM LEFT TO RIGHT INTO THE L2 VERTEBRAL BODY.¿ PATIENT DISCHARGED ON (B)(6) 2006.