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Catalog Number 200-04-21 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 09/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2009.Revision of optetrak components due to pain.This event occurred outside of the us, in (b)(6), and was discovered as part of active surveillance.
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, prexluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of loosening, wear, or infection, which led to pain.
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Event Description
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Index surgery: (b)(6) 2009.Revision of optetrak components due to pain.This event occurred outside of the us, in (b)(6), and was discovered as part of active surveillance.
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Search Alerts/Recalls
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