It was reported that a patient had thoracic surgery.The patient was implanted with zipfix, which failed.The patient experienced shortness of breath and chest pain, which prompted surgeon to have x-rays done and found the zipfix fractured.The patient had a revision surgery and had plates implanted.No additional information is available.This is report 1 of 1 for (b)(4).
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Device was used for treatment, not diagnosis.(b)(4).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.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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