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Catalog Number 04.614.508 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Neuropathy (1983); Positive antinuclear antibodies (ANA) (2015); Rash (2033); Chills (2191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: patient initials are (b)(6).Patient age and weight are not available for reporting.The date patient¿s symptoms began is unknown but reportedly began soon after initial implant date of (b)(6) 2015.Primary device product code is nkg.This code could not be entered due to system limitations.Additional device product code is kwp.Other number¿udi: ((b)(6), lot number unknown.The subject device is still reportedly implanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Mfr date: unknown.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, soon after the patient underwent a cervical fusion c2-t2 laminoplasty on (b)(6) 2015, the patient developed a rash along his neck, fatigue, flushing, chills, and has experienced increased neuropathy.It was further reported that since the surgery, the patient feels generally unwell and has tested positive for antinuclear antibodies (ana).This report is 20 of 26 for (b)(4).
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Manufacturer Narrative
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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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Search Alerts/Recalls
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