Description of Event or Problem · 0
THE FIRST IS FOR A PATIENT IN THE CERVICAL RETROSPECTIVE ARM. THE PATIENT IS (B)(6). PATIENT UNDERWENT AN ACDF AT C6-C7. 3.5 MONTHS AFTER THE SURGERY THE PATIENT HAD AN ADVERSE EVENT. A FALL THAT INVOLVED A C7 COMPRESSION FRACTURE AND SUBSIDENCE IN THE C7 VERTEBRAL BODY (CAUDAL TO THE FUSION). IT WAS A SINGLE EPISODE, IT WAS NOT SERIOUS, IT WAS UNANTICIPATED, IT WAS POSSIBLY RELATED TO THE DEVICE AND THERAPY WAS REQUIRED. THE PATIENT RECOVERED WITHOUT SEQUELAE. I'VE REACHED OUT TO THE SITE TO KNOW MORE ABOUT THE THERAPY THAT WAS REQUIRED. THE PATIENT WENT ON TO HAVE A SUCCESSFUL FUSION AND THE COMPRESSION FRACTURE WAS REPORTED TO BE HEALED AT 12 MONTHS. HERE IS THE COMPLETE INFORMATION I HAVE FOR THE PATIENT: 55-YEAR-OLD FEMALE, OVERWEIGHT, CURRENT SMOKER (10 CIGARETTES/DAY), ANXIETY/DEPRESSION, TYPE 2 DIABETES, COPD/EMPHYSEMA, RAYNAUD'S PHENOMENON, FIBROMYALGIA. PAST HISTORY: TEMPORAL ARTERITIS, SECONDARY ADRENAL INSUFFICIENCY, LOW SERUM CORTISOL LEVEL, THYROID NODULE, CHRONIC MIGRAINE, STEROID MYOPATHY, PTSD, MIXED HYPERLIPIDEMIA, NONRHEUMATIC AORTIC VALVE INSUFFICIENCY, PERIPHERAL NEUROPATHY. DIAGNOSED WITH STENOSIS, MYELOPATHY, NECK AND ARM PAIN (GREATER THAN 6 MONTHS). UNDERWENT ACDF AT C6-C7 WITH THE ACIS PROTI INTERBODY FUSION DEVICE SYSTEM (STANDARD 14MM, LORDOTIC (7°), 8MM IMPLANT HEIGHT) WITH VIVIGEN VIABLE CELL BONE MATRIX AND WITH DEPUY SYNTHES SKYLINE CERVICAL PLATE. POST-OPERATIVE TREATMENT: BRACING WITH A SOFT CERVICAL COLLAR (REPORTED DURING 6-WEEK FOLLOW-UP), PHYSICAL THERAPY (REPORTED DURING 3-MONTH FOLLOW-UP), BRACING WITH A HARD COLLAR (REPORTED DURING 6-MONTH FOLLOW-UP). PAIN MEDICATION: OXYCODONE- ACETAMINOPHEN (5-325MG) (TAKEN FOR 3 WEEKS POST-OPERATIVE), METHOCARBAMOL (750MG THREE TIMES A DAY (TAKEN FOR 2.5 MONTHS POST-OPERATIVE). AT 6-WEEK FOLLOW-UP SUBJECT WAS NOT COMPLIANT WITH POST-OPERATIVE TREATMENT (NOT WEARING PRESCRIBED BRACE). AT 3-MONTHS, 6-MONTHS, AND 12-MONTHS POST-OPERATIVE SUBJECT REPORTED TO BE COMPLIANT WITH POST-OPERATIVE TREATMENT. AT 12-MONTH FOLLOW-UP X-RAY SHOWS FUSION IS STABLE, C7 FRACTURE HAS HEALED. PATIENT COULD BENEFIT FROM CERVICAL FACET BLOCKS INJECTIONS TO HELP MANAGE PAIN. AT 3.5 MONTHS POST-OPERATIVELY THE PATIENT HAD AN ADVERSE EVENT REPORTED WITH A C7 COMPRESSION FRACTURE THAT OCCURRED DUE TO A FALL AND SUBSIDENCE IN THE C7 VERTEBRAL BODY (CAUDAL TO THE FUSION). IT WAS A SINGLE EPISODE, IT WAS NOT SERIOUS, IT WAS UNANTICIPATED, IT WAS POSSIBLY RELATED TO THE DEVICE AND THERAPY WAS REQUIRED. THE PATIENT RECOVERED WITHOUT SEQUELAE. PRE-OPERATIVELY THE VAS PAIN SCORES WERE 80 FOR NECK PAIN, 90 FOR RIGHT ARM PAIN, AND 0 FOR LEFT ARM PAIN. VAS PAIN AT 6 WEEKS WAS 90 FOR NECK PAIN, 70 FOR RIGHT ARM PAIN, AND 0 FOR LEFT ARM PAIN. NDI PRE-OPERATIVELY WAS 94, AT 6 WEEKS IT IMPROVED 80. RADIOGRAPHS: 6-WEEK AND 3-MONTH RADIOGRAPHS CAPTURED RADIOLUCENCY ALONG THE INTERFACE WITH THE VERTEBRAL BODY IN ADDITION TO CRANIAL SUBSIDENCE (>2.5MM). 6-MONTH AND 12-MONTH RADIOGRAPHS NOTE HEALING (PARTIAL CONSOLIDATION, BUT BRIDGING BONE NOT COMPLETE) IN ADDITION TO CAUDAL SUBSIDENCE (>2.5MM). 18-MONTH RADIOGRAPHS CONFIRM GRADE 3 - GRAFT INCORPORATION FUSION IN ADDITION TO CAUDAL SUBSIDENCE (>2.5MM).