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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 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 unknown date, patient will undergo a removal of unknown cannulated screws and washers from a talus and a subtalar fusion will be performed on (b)(6) 2021.No allegations were made against the devices.Patient status is unknown.This report is for (1) unk - screws: cannulated.This is report 1 of 3 for (b)(4).
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Search Alerts/Recalls
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