SYNTHES USA .0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 04.032.100S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Swelling (2091)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).Unknown if device is/not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and 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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Event Description
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It was reported that a patient developed an infection and underwent removal of hardware.A patient, who was implanted with a trochanteric fixation nail (tfn), presented with redness and swelling along the right hip.He was diagnosed with infection and underwent removal of tfn, a lag screw and two dual force screws on (b)(6) 2016.A culture was taken; results are pending and will not be available.It was noted that this was the patient's third procedure.There was no surgical delay.It was reported that the procedure was successfully completed.Patient outcome is unknown.There are no plans at this time to implant other devices.No additional information available.This report is 2 of 4 for (b)(4).
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Search Alerts/Recalls
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