Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Irritation (1941)
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Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.Date of event: unknown.This report is for an unknown arthrodesis nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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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Event Description
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It is reported the patient was returned to surgery on (b)(6) 2016 for the removal of a 6.0 titanium locking screw that had backed out of an arthrodesis nail and was irritating the patient's soft tissue.Procedure was completed successfully.Procedure was completed successfully with no further harm to patient.This report is for an unknown arthrodesis nail.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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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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Event Description
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It was reported there was no delay during the procedure.
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Search Alerts/Recalls
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