SURGICAL MESH

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. MICHELLE ET AL. (2014). FUSION FOLLOWING LATERAL MASS RECONSTRUCTION IN THE CERVICAL SPINE. J NEUROSURG SPINE 22:139-150. USA THE AUTHORS PRESENT A SERIES OF 7 CASES IN WHICH LATERAL MASS RECONSTRUCTION WITH A CAGE OR FIBULAR STRUT GRAFT WAS USED TO PROVIDE LOAD-BEARING SUPPORT, INCLUDING 1 CASE OF BILATERAL CAGE PLACEMENT. THE 7 CASES OF LATERAL MASS RECONSTRUCTION INCLUDED 5 PATIENTS WITH CAGE PLACEMENT AND 2 PATIENTS WITH FIBULAR STRUT GRAFT PLACEMENT. IN ALL CASES, THE LATERAL MASS COMPLEX WAS REMOVED IN CONJUNCTION WITH TUMOR RESECTION. TO PERFORM THIS PROCEDURE, MOBILIZATION AND CONTROL OF THE VERTEBRAL ARTERY WAS NECESSARY. ONCE THE RESECTION WAS COMPLETE, THE CAGE WAS CAREFULLY CONTOURED TO FIT SNUGLY BETWEEN THE HIGHEST LEVEL OF RESECTION (OCCIPITAL CONDYLE, LATERAL MASS OF C-1, OR A SUBAXIAL LATERAL MASS) AND THE UPPER SURFACE OF THE LOWEST REMAINING LATERAL MASS. CAGES WERE VARIABLY SECURED WITH SMALL FRAGMENT SCREWS (SYNTHES), BUT ALL CAGES WERE SECURED TO THE POSTERIOR INSTRUMENTATION VIA A LATERAL MASS SCREW PLACED THROUGH THE CAGE. ALL CAGES WERE PACKED WITH ALLOGRAFT BONE TO ENSURE ARTHRODESIS BETWEEN CAGE AND BONE. THE (B)(6) WOMAN INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL WITH NECK PAIN. SHE UNDERWENT MRI AND CT SCANNING AS WELL AS BIOPSY SAMPLING, WHICH DEMONSTRATED A CHONDROSARCOMA INVOLVING C-2, C-3, AND C-4. POSTERIOR INSTRUMENTATION FROM THE OCCIPUT TO T-5 WAS IN PLACE FROM THE FIRST STAGE OF THE PROCEDURE. TO PROVIDE LOAD-BEARING CAPABILITIES, A SYNMESH CAGE (SYNTHES) TO SPAN FROM THE RIGHT C-1 LATERAL MASS TO THE RIGHT C-6 LATERAL MASS WAS SIZED TO FIT. A SYNAPSE SCREW (SYNTHES) WAS DRIVEN THROUGH THE CAGE SUCH THAT THE CAGE COULD BE LOCKED TO THE 3.5-MM ROD.THE CAGE WAS PLACED IN THE POSITION, AND THEN 2 SMALL FRAGMENT SCREWS WERE PLACED LOCKING IT IN POSITION TO THE SPINE, ONE INTO THE LATERAL MASS OF C-1 AND THE OTHER INTO THE LATERAL MASS OF C-6. AFTER THE CAGE WAS POSITIONED, BOTH RODS WERE REPLACED TO SPAN T-5 THROUGH THE OCCIPUT AND WERE LOCKED TO THE CAGE USING THE SYNAPSE SCREW. POSTOPERATIVELY, THE PATIENT UNDERWENT PROTON-BEAM RADIATION THERAPY FOR RESIDUAL DISEASE. FOURTEEN MONTHS AFTER SURGERY, SHE EXPERIENCED ACUTE NECK PAIN AND DIFFICULTY SWALLOWING. IMAGING DEMONSTRATED FRACTURE OF THE POSTERIOR RODS, AND THE PATIENT UNDERWENT REDUCTION OF HER DEFORMITY WITH REMOVAL AND REINSERTION OF POSTERIOR INSTRUMENTATION WITH REINFORCEMENT OF THE CONSTRUCT. SHE DIED OF HER DISEASE JUST UNDER 2 YEARS AFTER HER INITIAL RESECTION. THIS IS REPORT 2 OF 5 FOR (B)(4). THIS REPORT IS FOR UNKNOWN A SYNMESH CAGE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

Additional Manufacturer Narrative

(B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.