PYRAMESH IMPLANT SYSTEM

Description of Event or Problem

IT WAS REPORTED IN A LITERATURE ARTICLE CONTAINING A RETROSPECTIVE CASE SERIES OF FIFTY CONSECUTIVE PATIENTS (27 WOMEN AND 23 MEN) WHO UNDERWENT SURGERY BETWEEN 2003 AND 2010. MEAN PATIENT AGE WAS (B)(6) YEARS. ALL PATIENTS HAD TUMOR DISEASE WITHIN THE VERTEBRAL BODY. OF THE 50 PATIENTS, 29 HAD A KYPHOTIC COLLAPSE NOTED ON PREOPERATIVE MRI IMAGES. SINGLE OR MULTILEVEL, CONTIGUOUS SUBTOTAL VERTEBRECTOMY WAS PERFORMED RANGING FROM T1 TO L4 (38 THORACIC AND 12 LUMBAR). THREE-COLUMN SPINAL STABILIZATION WAS ACHIEVED USING POSTERIOR PEDICLE SCREW FIXATION AND VERTEBRAL BODY RECONSTRUCTION, WITH A TITANIUM CAGE INTRODUCED THROUGH THE POSTERIOR TRANSPEDICULAR ROUTE. THE MEAN FOLLOW UP WAS 17 MONTHS. POSTOPERATIVE NEUROLOGICAL STATUS WAS MAINTAINED OR IMPROVED IN ALL PATIENTS. AT LAST REVIEW, 14 PATIENTS WERE ALIVE, WITH A MEAN SURVIVAL OF 36 MONTHS. THE MEAN SURVIVAL OF THE 36 PATIENTS THAT DIED WAS 19 MONTHS. IT WAS REPORTED THAT ONE PATIENT EXPERIENCED POSTOPERATIVE LEG WEAKNESS BUT RECOVERED WITH 6 WEEKS OF REHABILITATION. ONE PATIENT REMAINED UNCHANGED AFTER SURGERY. THREE PATIENTS UNDERWENT FURTHER PALLIATIVE TUMOR DEBULKING FOR RECURRENT SYMPTOMATIC NEUROLOGIC AL COMPRESSION, WITHOUT REQUIRING REVISION OF THE SPINAL INSTRUMENTATION. ONE PATIENT, PRESENTING WITH RECURRENT COMPRESSIVE PLASMACYTOMA 26 MONTHS POST-OP, WAS SUCCESSFULLY PALLIATED WITH FURTHER CHEMOTHERAPY. OF THE PATIENTS WHO DIED, ALL BUT 5 WERE AMBULANT AT LAST FOLLOW UP. 4 OF THE 5 NONAMBULANT PATIENTS WERE IMMOBILE DUE TO PROGRESSION OF SYSTEMIC DISEASE AND DID NOT HAVE PARALYSIS FROM RECURRENT SPINAL TUMOR. ONE PATIENT DIED 14 DAYS AFTER SURGERY DUE TO A SEVERE CASE OF POSTOPERATIVE PNEUMONIA. TWO PATIENTS SUFFERED EPIDURAL WOUND HEMATOMA WITH EMERGENCY HEMATOMA EVACUATION. ONE PATIENT DEVELOPED POSTOPERATIVE PNEUMONIA WHICH WAS SUCCESSFULLY TREATED WITH ANTIMICROBIAL THERAPY. ONE PATIENT DEVELOPED UNCOMPLICATED DEEP VENOUS THROMBOSIS. TWO PATIENTS DEVELOPED DELAYED SETTLING OF THE INTERBODY CAGE INTO THE INFERIOR VERTEBRA WITH RECURRENT PAIN 2 MONTHS POST-OP. PAIN WAS SUCCESSFULLY MANAGED WITH ANALGESIA.

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.