WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 CALC RECONSTRUCTION PL 9 HOLES/72; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
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Model Number 245.99 |
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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Additional device product codes hrs.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.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.(b)(4).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 removal of ankle plates and hardware occured.The shaft remained in the patient and the broken head was removed from the patient.The procedure and patient outcome were unknown.This report is for (1) 2.7 calc reconstruction pl 9 holes/72.This is report 2 of 11 for complaint (b)(4).
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Search Alerts/Recalls
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