Report 12 of 14 unpublished clinical data was obtained as part of clinical evaluation.Per the draft cer tec-0276, in clinical data set 1: between january 2015 to march 2023, 23 patients (23 wrists) underwent a total wrist arthrodesis surgery at a uk hospital.Patients had an average age of 53.8 years ± 13.3 years (range 26-86 years).The mean follow-up time was 5 years (range 0.5-9.2 years).In total, 14 wrists were for the right side and 9 were for the left side.All patients used the acumed total wrist fusion plate system and used acumed instrumentation to place the implanted device.In total, 10 neutral plates (70-0362), 5 left small plates (70-0327), 3 right small plates (70-0328), and 5 right standard plates (70-0326).The majority of patients also underwent a concomitant procedure during their total wrist arthrodesis (n=17/23; 73.9%).One patient was readmitted that day after surgery for pain and swelling.They were treated with evaluation and an analgesia; no further treatments were required.Another patient continued to have symptoms related to osteoarthritis and carpal tunnel syndrome; however, these were not related to the total wrist arthrodesis.A patient with a recurrent wound from a low-grade infection had their plate removed after arthrodesis.This resolved the wound problem.Five plates were removed due to patient discomfort or soft tissue irritation caused by plate prominence.Thus, in total, six plates (26.1%) of plates were removed after arthrodesis.The remaining 17 plates did not have complications.There are 14 related report numbers for this event 3025141-2023-00576 through 3025141-2023-00589.
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