WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP LAT ANT CLAV PL/11H/113; PLATE, FIXATION, BONE
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Model Number 02.112.048 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Type
Injury
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Manufacturer Narrative
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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 underwent a fracture fixation for a shaft fracture utilizing a va-lcp anterior plate.Postoperatively, the patient had decreased range of motion, pain with range of motion.There was a union of fracture after 6 weeks duration.Patient outcome is unknown.No further information is available.This report is for one (1) 2.7/3.5 va-lcp lat ant clav pl/11h/113.This is report 1 of 8 for (b)(4).
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