SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.124.414 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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Additional patient information: patient height is 165 cm and bmi is (b)(6).Date of event is unknown.Additional codes: hrs, hwc.Udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: 14.Jan.2015.Expiry date: 01.Jan.2025.No nonconformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient, who was implanted with one (1) distal femoral locking plate and an unknown number of locking screws on (b)(6) 2015, has experienced painful hardware.The patient reported that the hardware bothers her all the time and she reportedly suspected that she was having an allergic reaction to the previously implanted distal locking plate and screws.The plate and locking twelve (12) screws were explanted on (b)(6) 2017.The patient was reportedly fully healed.During the procedure, the surgeon reported that there were no signs of an allergic reaction.Blood work showed no signs of an allergic reaction or of an infection.The treating physician will, reportedly test the patient for allergies.It explanted devices were easily removed intact, without any additional medical intervention being required and without any patient harm.The explanted devices are not available for investigation.No additional information is available.This is report 1 of 13 for (b)(4).
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