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Catalog Number 497.125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.(b)(4).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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Device report from synthes europe reports an event in (b)(6) as follow: it was reported that the patient underwent surgeries for adjusting veptr size on (b)(6) 2013 and (b)(6) 2014 respectively.On (b)(6) 2014, it was noticed that patient had (b)(6) infection and insufficient fusion on the wounded area.A cultivation test was performed and the result was (b)(6).On aug 22, 2014, patient underwent removal procedure and only the veptr, stabilized between the left 5th lib and the ileum was removed.Patient outcome was reported as well.Reportedly, the veptr treatment has continued.Patient¿s past and future patient histories are captured in linked complaints (b)(4) respectively.This report is for one (1) ti distraction lock.This is report 4 of 9 for (b)(4).
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Manufacturer Narrative
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Device history records review was completed for part# 497.125, lot# 7723436.Manufacturing location: (b)(6), manufacturing date: jul 02, 2014.The review was done for the parent lot number (7723436) and all raw material lots used to manufacture the device.Component (b)(4) ¿ raw material, lot number 6660255.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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