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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient height is 157cm.This report is for an unknown quantity of unknown cerclage wires.Part and lot numbers were not available for reporting.Other number¿udi: part number unknown, udi is unavailable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is 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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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient was initially treated with a locking compression plate (lcp) for an infected femur fracture.The patient needed further treatment on (b)(6) 2016 due to infection-related right femoral periprosthetic pseudarthrosis.The treatment comprised cancellous bone graft from the left posterior upper iliac crest, pseudarthrosis revision and resection.The implanted lcp-plate and hardware remained in situ at that time.The patient underwent another revision procedure on (b)(6) 2016 and the plate and associated hardware were explanted.This event is captured and reported under linked complaint (b)(4).This report is for an unknown quantity of unknown cerclage wires.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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Date of report was initially reported as oct 21, 2016, but should have been oct 06, 2016 as per the received update.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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