Description of Event or Problem · 1
THIS IS A PATIENT WHO ON (B)(6) 2021 UNDERWENT ANTERIOR CERVICAL FUSION SURGERY IN WHICH SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN, PRODUCT CODE 5094 WAS USED. THE PRODUCT WAS APPLIED TO THE INTERVERTEBRAL DISC AT C 3/4 AND C 4/5 BEFORE CAGE INSERTION AND THROUGHOUT THE TISSUE AFTER INSERTION, AND IT WAS WASHED THOROUGHLY. FROM THE INFORMATION AVAILABLE, THE SURGERY WAS UNCOMPLICATED. AFTER AWAKENING FROM ANESTHESIA, DYSPHAGIA OCCURRED. THE PATIENT ALSO COULD NOT SWALLOW SALIVA AND PATIENT WAS TRANSFERRED TO ICU WITH POSTOPERATIVE OROPHARYNGEAL DYSPHAGIA. PATIENT IMPROVED AND WAS DISCHARGED FROM ICU ABLE TO WALK AND APPEARED NORMAL BUT STILL WITH SEVERE DYSPHAGIA. THE FINDINGS OF A SPEECH THERAPIST AND AN OTOLARYNGOLOGIST INDICATE THAT THE ENTRANCE TO THE ESOPHAGUS DID NOT OPEN DUE TO SWELLING OF THE BASE OF THE TONGUE AND HYPOPHARYNX. THE SURGEON CONSIDERED IF PATIENT HAD EXPERIENCED AN ALLERGIC REACTION TO THE PORCINE GELATIN IN SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN. CLINICAL QUESTIONS WERE ASKED, AND INFORMATION WAS PROVIDED THAT PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2021 WHERE THERE WAS NO PROBLEM WITH SWALLOWING AND NO NEUROLOGICAL SYMPTOMS. THERE WAS A MARKED IMPROVEMENT FROM A PREOPERATIVE JOA (JAPANESE ORTHOPAEDIC ASSOCIATION) SCORE OF 8.5 POINTS TO A POSTOPERATIVE JOA SCORE OF 16 POINTS (MAXIMUM TOTAL SCORE BEING 17). POSTOPERATIVE OROPHARYNGEAL DYSPHAGIA IS ONE OF THE MOST COMMON COMPLICATIONS ASSOCIATED WITH ACSS (ANTERIOR CERVICAL SPINE SURGERY) (ANDERSON, K.K. ET AL., 2013, OROPHARYNGEAL DYSPHAGIA AFTER ANTERIOR CERVICAL SPINE SURGERY: A REVIEW, GLOBAL SPINE JOURNAL). THE CAUSES OF OROPHARYNGEAL DYSPHAGIA AFTER ACSS ARE MULTIFACTORIAL, INVOLVING NEURONAL, MUSCULAR, AND MUCOSAL STRUCTURES. THE CONDITION IS USUALLY TRANSIENT, MOST OFTEN BEGINNING IN THE IMMEDIATE POSTOPERATIVE PERIOD BUT SOMETIMES BEGINNING MORE THAN 1 MONTH AFTER SURGERY. THE INCIDENCE OF DYSPHAGIA WITHIN ONE WEEK AFTER ACSS VARIES FROM 1 TO 79% IN THE LITERATURE. THIS WIDE VARIANCE CAN BE ATTRIBUTED TO VARIATIONS IN SURGICAL TECHNIQUES, EXTENT OF SURGERY, AND SIZE OF THE IMPLANT USED, AS WELL AS VARIATIONS IN DEFINITIONS AND MEASUREMENTS OF DYSPHAGIA, TIME INTERVALS OF POSTOPERATIVE EVALUATIONS, AND RELATIVELY SMALL SAMPLE SIZES USED IN PUBLISHED STUDIES. IN SUMMARY, THERE SEEMS TO BE LITTLE THAT POINTS IN THE DIRECTION OF AN ALLERGIC REACTION DUE TO LACK OF ANY SYMPTOMS OF THIS. RATHER IT POINTS TOWARDS THAT PATIENT EXPERIENCED POSTOPERATIVE OROPHARYNGEAL DYSPHAGIA AS A RESULT OF THE ANTERIOR CERVICAL SPINE SURGERY (ACSS) PER SE. IN CONCLUSION, THIS EVENT IS NOT CAUSED BY THE USE OF SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN.