Description of Event or Problem · 0
AT 2.5 MONTHS AFTER SURGERY THE SITE REPORTED WOUND INFECTION. PATIENT HAD SURGERY ON (B)(6) 2020. ADVERSE EVENT WAS REPORTED ON (B)(6) 2020 THIS ADVERSE EVENT WAS CONTINUOUS, IT HAD MODERATE SEVERITY, IT WAS NOT SERIOUS, IT WAS UNANTICIPATED, IT WAS NOT RELATED TO THE TYBER MEDICAL TRAUMA SCREW SYSTEM, THERAPY WAS REQUIRED, AND THE PATIENT RECOVERED WITH SEQUELAE. THE ADVERSE EVENT CESSATION DATE WAS 2 MONTHS AFTER THE ADVERSE EVENT STARTED (CESSATION DATE OF (B)((6) 2021). I REACHED OUT TO THE SITE TO GET MORE INFORMATION, AS I DON'T KNOW WHAT TREATMENT WAS INVOLVED AND I DON'T KNOW WHAT SEQUELAE THE PATIENT HAD AFTERWARDS. I SAW FROM THE MEDICATION LOG THAT THE PATIENT WAS TREATED WITH BACTRIM FOR 2 WEEKS (FROM (B)(6) 2021) WHICH SPANS OVER WHEN THE ADVERSE EVENT CESSATION DATE OCCURRED. THE PATIENT HAD A FRACTURE REPAIR OF A CLOSED TRIMALLEOLAR FRACTURE. THE SURGERY INVOLVED 3 OF OUR SCREWS AND A PLATE (DEPUY SYNTHES PLATE TOO, BUT DIDN'T SAY TYPE). THE PATIENT DID GO ON TO FUSE AT (B)(6) 2021, RETURNED TO NORMAL ACTIVITY AND WAS CLINICALLY HEALED. SINCE THIS ONE INVOLVED INFECTION I THINK IT IS REPORTABLE, EVEN THOUGH THEY SAID IT WASN'T RELATED TO THE TYBER MEDICAL TRAUMA SCREW SYSTEM. I WILL MENTION THAT WHEN YOU REPORT IT MAKE SURE YOU MENTION THAT A PLATE WAS INVOLVED TOO - IT WAS NOT JUST OUR HARDWARE.