SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/36MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.231.236 |
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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(b)(6).Additional codes: hrs, hwc.(b)(4).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.The manufacture date is unknown.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 5 of 13 for (b)(4).
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