A review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.Patient #40 index procedure was performed on (b)(6) 2015.In (b)(6) 2019 the patient asked for more distraction and a longer implant with extension was implanted.On (b)(6) 2022 apifix was notified that patient #40 (c.L) had undergone an implant removal surgery on (b)(6) 2022.Post-explantation x-rays taken ten days after the removal were received.The images show that the patient's curve is at <10° despite multiple attempts to obtain additional information, specifically, the reason for the removal.No additional information had been provided.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event involved a removal surgery.The implant was electively removed with no report of patient harm having occurred.Apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this as an adverse event.
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