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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Patient date of birth is not provided.Exact date of event is unknown.This report is for one (1) unknown - tibial nail.Udi is not available.Exact date of implant procedure is unknown.The complainant part is not expected to be returned to manufacturer.Pma/510(k) number is unknown as this report is for an unknown-tibial nail.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 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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Event Description
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It was reported that a patient with a history of sweet's disease and obesity had a tibial nail implanted 15 years ago on an unknown date.Recently, the patient began to experience pain in the ankle; the surgeon decided to remove the implants.On (b)(6) 2016, patient underwent procedure for implant removal.One (1) titanium solid tibial nail, three (3) titanium 4.9mm screw, one (1) stainless steel 6-hole dynamic compression plate, six (6) 3.5mm cortex screws, and one (1) 4.5mm cannulated screw were removed intact.Patient was not revised with any new implants.There was no surgical delay and procedure was completed successfully.Patient status was reported as stable.This report is for one (1) unknown - tibial nail.This is report 1 of 5 for (b)(4).
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Search Alerts/Recalls
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