Model Number 179702000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Dizziness (2194)
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Event Date 01/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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It was reported by legal that patient had several post op issues following posterior spinal instrumentation with depuy expedium (l5-s1).Left l5-s1 transforaminal lumbar interbody fusion with placement of a depuy devex 10 x 28 transforaminal lumbar interbody fusion titanium cage and anterior spinal fusion with autograft at l5-s1.Uneventful surgery per op report.Nothing out of the ordinary.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Manufacturer Narrative
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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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