It was reported that a patient is experiencing pain, swelling and a reported infection since a trim it pin was implanted in (b)(6) 2016.The rep stated that the trim it pin was implanted for a hammertoe correction.Additional information has been requested.Additional information received on 10/10/2018: the rep confirmed that the original procedure took place on (b)(6) 2016.The original procedure was a hammertoe correction procedure on toes, 2, 3, and 4.The following part and lot numbers were implanted during the original (b)(6) 2016 procedure: ar-4151ds: lot: 10048351 / qty.2; ar-4151ds: lot: 10029027 / qty.1.The rep stated they are not aware of the specific date of when the patient started experiencing pain, swelling, discomfort, and reported infection.The rep reported that they were not given any specifics on type of infection, or if there has been testing done.There are not any details on current treatment for the patient's reported infection and symptoms.The rep stated that the same surgeon who performed the original procedure does plan to remove the pin at the same location of the original surgery.The rep confirmed that as of now there has not been a removal surgery scheduled.The rep stated that they were able to read the operative report.The implant log confirmed that the trim it pins were used on the third and fourth as well.Additional information received on 10/22/2018: the rep confirmed that a total of three ar-4151ds were implanted during the original procedure on toes 2, 3, and 4.The rep confirmed that nothing else was implanted during the original procedure.
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