WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TIBIAL ANTIBIOTIC COATED; 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 Type
Injury
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Manufacturer Narrative
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This report is for an unknown nails: tibial antibiotic coated/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 an unknown date, the patient returned to surgery for removal of unknown antibiotic nail and is still infected.The patient has refused to receive iv antibiotics per surgeon.The patient's canal was reamed and irrigated and stimulan beads were inserted.This is an extension of complaint from (b)(6) 2020.The procedure outcome is unknown.There was patient consequence.This report is for one (1) unk - nails: tibial antibiotic coated.This is report 1 of 2 for (b)(4).This complaint is related to (b)(4).
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Search Alerts/Recalls
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