GRAFTON ORTHOBLEND SYR DBM GEL 5CC FLWBL GRAFTON

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 POSSIBLE REMOVAL OF THE EXISTING ZIMMER CERVICAL PLATE DUE TO ADJACENT LEVEL DISEASE, IT WAS PREVIOUSLY IMPLANTED AT CR-7, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAS TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. (NO EQUIPMENT BROKE OR MALFUNCTIONED) A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER WHICH HE WAS ABLE TO DO. A NEW GRAFT WAS PLACED, THE PLATE WAS REMOVED BUT NOT REPLACED AND IMPLANTED WITH SCREWS. ONCE THE CASE WAS COMPLETED NEURO MONITORING SHOWED THAT ONE SIDE OF HER BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THERE WAS A SURGICAL DELAY WHEN THE GRAFT HAD TO BE REMOVED. THE PATIENT WAS TAKEN TO THE ICU AND HAD NOT PROGRESSED VERY WELL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORTS: MW5120548, MW5120549, MW5120550, MW5120551, MW5120552, MW5120553.