Device Problems
Corroded (1131); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown screw/unknown lot.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.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: it was reported that the patient was experiencing severe pain so a revision procedure was performed.After removing a plate, it was discovered that it had rusted on the cortical screw section of the combi-holes; the locking holes seemed un-affected.The device had been in the patient since (b)(6) 2014.This report is for an unknown screw.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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(b)(4) low patient ph balance that occurred as a result of the rusted device.Device 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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Update: per the surgeon, the damage/rust on the plate caused a low ph balance in the patient.
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Manufacturer Narrative
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(b)(4) patient's low ph balance.It is unknown if the rust caused the low ph balance or if the low ph balance caused the rust.Device 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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