It was reported that post operatively the patient had experienced pain, foot drop, muscle loss and paralysis in the left leg.After a motor vehicle accident the patient was implanted with multiple hardware including plates, screws and nails.It was reported that she also had traction pins post operatively.The patient reports multiple falls secondary to the foot drop and paralysis.The products have not been removed.This is report 1 of 15 for (b)(4).
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Date of event: unknown.Implant/explant date: device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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