Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .
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Related manufacturer reference number: 1627487-2021-01967 related manufacturer reference number: 1627487-2021-01968 it was reported that the patient was experiencing severe right leg pain post-implant while in recovery.The patient was assessed by the physician and the physician made the decision to pull the entire system due to the severity of their pain.Following the patient's release, it was reported that they were able to move their leg, and they were prescribed narcotics and given an order for physical therapy.
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