This report is a response to uf report # (b)(4) which was reported to amt by fda on 06/28/2021.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt reached out to the reporter and retrieved the failed device for analysis.The device was analyzed and the reported failure was confirmed.A device history review was performed for the lot with no anomalies detected in the record.Based on the provided information, the reported problem did not occur due to a manufacturing defect, but due to a combination of excessive stress and patient/environment usage conditions.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if future information or analysis changes the conclusion of this report.
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