WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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Model Number 02.124.410 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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Additional: hrs and hwc.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 removal of the variable angle -locking compression plate (lcp) curved condylar plate.It was discovered as broken due to unknown reasons.The surgeon decided to proceed with a total knee revision.The plate was broken through the non-locking portion of the fifth (5th) hole in the shaft closest to the distal end.The patient had an implant of plate and unknown screws on an unknown date.The screws and plate fragments were removed successfully and easily without additional intervention.Procedure was successfully completed with no surgical delay.Procedure had no adverse effect to the patient.Concomitant device: unknown screws (part#unknown, lot#unknown, quantity, unknown).This report is for one (1) 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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