Catalog Number 08.501.001.01S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Manufacturing location: (b)(4).Manufacturing date: november 22, 2012.Expiry date: november 01, 2017.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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Device report from synthes europe reports an event in (b)(6) as follows: the patient was implanted with the zipfix system on (b)(6) 2106.Post-operatively the patient presented with mediastinitis.It was confirmed this was not an infection; however, the patient did require a revision to remove three zipfix devices on (b)(6) 2016 due to the reaction.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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Udi: (b)(4).Device history record (dhr) review was performed on part # 08.501.001.01s, lot # 9933414: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 13-july-2016, expiry date: 01-july-2021.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) 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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