WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: HINDFOOT ARTHRODESIS NAIL; NAIL, FIXATION, BONE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This report is for an unk - nails: hindfoot arthrodesis nail /unknown lot.Part and lot numbers are unknown; udi number is 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on (b)(6) 2021,the patient underwent for a revision surgery.During the surgery, the surgeon was removed the hind foot fusion nail.It is unknown if there is surgical delay reported and if the procedure was successfully completed.This complaint involves (1) device.This report is for an unk, nails: hindfoot arthrodesis nail.This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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