Description of Event or Problem · 0
ON NOVEMBER 16, 2023 PMT WAS NOTIFIED OF A REVISION INVOLVING PROVIDENCE MEDICAL TECHNOLOGY (PMT) DEVICES. THE REVISION PROCEDURE WAS ON (B)(6) 2023. IT IS NOT KNOWN WHEN THE INDEX PROCEDURE WAS PERFORMED. THE INDEX PROCEDURE INVOLVED AN ANTERIOR AND POSTERIOR FUSION. ROI-C WAS IMPLANTED AT C3-4, C4-5, C5-6, C6-7. IN ADDITION TO THE STANDALONE ROI-C INTERVERTEBRAL BODY CAGE, THE PATIENT RECEIVED A 4 LEVEL MAXAN ANTERIOR PLATE AND SCREWS. PMT PRODUCTS CAGE-X 4MM AND BONE SCREWS WERE IMPLANTED POSTERIORLY AT C3-4, C4-5, C5-6, C6-7. A FEW WEEKS LATER THE PATIENT WENT BACK TO THE DOCTOR AND IT WAS DISCOVERED THAT THE MIDDLE PORTION OF THE ANTERIOR CONSTRUCT PULLED FORWARD TAKING OUT THE MIDDLE ROI-C CAGE AND THE MIDDLE SCREWS OF THE MAX ANTERIOR PLATE. THE DOCTOR MENTIONED THAT THE PATIENT HAD POOR BONE DENSITY. IT IS ALSO BELIEVED THAT BECAUSE OF THE PATIENT'S COMORBIDITIES AND IN CONJUNCTION WITH THE OTHER DEVICES MAY HAVE CAUSED THE PATIENT TO GO INTO KYPHOSIS FORCING THE ANTERIOR CONSTRUCT FORWARD AND THE POSTERIOR DEVICES TO MIGRATE. THERE WAS NO BREAKAGE OF THE PMT DEVICES NOTED. THE PATIENT WENT THROUGH A REVISION SURGERY WHERE THE ANTERIOR CONSTRUCT WAS REMOVED AND REPLACED ALONG WITH THE POSTERIOR CONSTRUCT BEING REPLACED BY LATERAL MASS SCREWS AND RODS. IT WAS CONFIRMED ON (B)(6) 2023 THAT THE PATIENT IS RECOVERING WELL FROM THE REVISION SURGERY.