CAGE

Description of Event or Problem

IT WAS REPORTED DURING AN ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF) PROCEDURE ON (B)(6) 2013, WITH A CAGE, PLATE AND SCREWS, A DRILL BIT WAS USED THAT DID NOT HAVE A STOP TO IT. IT WAS NOT UNTIL THE SURGEON WAS USING THE INSTRUMENTS AND MAKING HIS HOLES FOR THE SCREWS, THAT HE NOTICED THAT THERE WAS NO STOP. WITHOUT THE DEPTH STOP, IT IS UNDETERMINED HOW DEEP THE DRILL WENT. THE SURGEON COMPLETED THE SURGERY AS PLANNED WITH THE CORRECT DRILL BIT. PATIENT IS DOING WELL AND WAS DISCHARGED. IT WAS LATER REPORTED THAT THE SYNAPSE DRILL BIT WAS ACCIDENTALLY PLACED IN THE ACDF GRAPHIC CASE. THE SYNAPSE DRILL BIT HAD A STOP BUT WAS DESIGNED TO WORK WITH A DIFFERENT DRILL GUIDE THAN THE ONE THAT WAS UTILIZED. THE PATIENT¿S COUNSEL REPORTED THAT DURING A C5-C6 ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE ON (B)(6) 2013, ¿THE SURGEON USED AN UNGUARDED DRILL BIT WHICH PIERCED THROUGH THE ANTERIOR RIGHT SIDE OF THE PATIENT'S C5 VERTEBRAE AND STRUCK HER SPINAL CORD.¿ THERE WAS ALSO A DURAL LEAK. IT WAS ALSO REPORTED ¿THE SURGEON INSERTED A STABILIZING PLATE THAT WAS TOO BIG AND THE SCREWS DUG INTO THE PATIENT'S C6-C7 DISC, ULTIMATELY NECESSITATING A SECOND CORRECTIVE SURGERY ON (B)(6) 2014.¿ THE PATIENT UNDERWENT A REVISION SURGERY AT C5-6 ON (B)(6) 2014 DUE TO CHRONIC PAIN, CERVICAL SPONDYLOSIS WITH MYELOPATHY, MALPOSITIONED PLATE AND INFERIOR SCREWS, AND A POSSIBLE NON-UNION. THE POST-OPERATIVE X-RAYS REVEALED THAT THE C6 SCREWS, WHICH HAD BEEN PARTIALLY IN THE BODY OF C6 AND PARTIALLY IN THE BODY OF C6-7, HAD MIGRATED INTO THE C6-7 CARTILAGE DISK ENTIRELY. AS THE CAGE SETTLED IN, THE PLATE EXTENDED ITSELF DOWN OVER THE C6-7 DISC LEVEL. IT WAS ALSO NOTED THAT THE UPPER SCREWS COULD BE REMOVED WITH ONLY MODERATE DIFFICULTY DUE TO BREAKAGE OF ONE OF THE FOUR PARTS OF THE RIGHT CRUCIATE SCREW. THE TIMING OF THE SCREW BREAKAGE IS UNKNOWN. THE SURGEON DECIDED TO REMOVE THE PLATE AND SCREWS AND LEAVE THE CAGE IMPLANTED DUE TO CONCERN THAT IT MIGHT BE DAMAGING TO THE DISK OVERTIME, WITH TOGGLING AS THE PATIENT MOVES, THIS COULD LEAD TO ACCELERATED DEGENERATION OF THE DISC AND POTENTIALLY AN EARLY NEED FOR FUSION AT THE C6-7 LEVEL. THIS PART IS AN UNKNOWN SYNMESH CAGE. THIS IS 7 OF 9 REPORTS FOR COMPLAINT # (B)(4).

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS PART IS AN UNKNOWN SYNMESH CAGE. PART WAS NOT EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.