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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 used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).The device history review (dhr) was performed for part number 497.125, lot number 6752572.The review was done for the parent lot number (6752572) and all raw material lots used to manufacture the device.The review results were: manufacturing site: (b)(4), manufacturing date: 01nov2011, part number 497.125, lot number 6752572.No nonconforming records were generated during production.Review of the device history records showed that there were no issues during the manufacture that would contribute to this complaint condition.No nonconforming records were generated during production.Review of the device history records showed that there were no issues during the manufacture that would contribute to this complaint condition.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 on an event in japan as follows: it was reported that on (b)(6) 2012 the patient underwent surgeries for the following: two (2) stabilizations were performed.Hybrid type veptr (size 10) was applied, ranging from the left 5th lib to the ileum.Hybrid type veptr (size 7) was applied, ranging from the left 7th lib to the 3rd lumbar spine.On (b)(6) 2012, a decrease in mep was noticed.On (b)(6) 2012, the poser-operative infection on the wounded area was confirmed.A necessary treatment (unknown treatment details) was performed.The patient's outcome was reported as well.This complaint involves (16) parts.Patient¿s past and future histories are captured and linked in these complaints: 1 of 3 (b)(4).This report is 6 of 16 for (b)(4).This complaint involves 1 part.
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Manufacturer Narrative
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The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review was performed for raw material component 21100 ¿ raw material, lot number 6149668.No nonconforming records were generated during production.Review of the device history records showed that there were no issues during the manufacture 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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