WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 38MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
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Model Number 202.838 |
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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Product complaint #: (b)(4).Additional product code: hwc.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.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 removal surgery.During the surgery, all devices were intact, no items were broken, and were removed successfully and without difficulty.Originally, the patient underwent for removal hardware of a left tibial shaft fracture for infection on (b)(6) 2020.The current removal surgery was completed successfully without any delay.The patient was fin postoperatively.This complaint involves thirteen (13) devices.This report is for (1) 2.7mm cortex screw self-tapping 38mm.This report is 12 of 13 for (b)(4).
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Search Alerts/Recalls
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