The event is not a death situation.There was no life-threatening injury or any serious injury that resulted in permanent impairment of body function or structure reported.However, there was illness in the sense that the patient experienced pain after the original implantation due to a mal-positioned cage.The pain led to the re-intervention.Although there was no device defect or malfunction reported in this case, the mal-positioned implant had led to a revision and therefore failed to perform as intended.For this reason, this event was reported to fully comply with 21 cfr 803.Not device defect related.
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