Catalog Number 320-42-00 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/06/2016 |
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, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Revision due to infection.The case report form indicates the event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.Interspace implanted and subsequently removed (b)(6) 2016.Index surgery (b)(6) 2016.
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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, the device specific information was not provided, precluding a review of the device history record.Updated the index surgery date.
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Event Description
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Index surgery: (b)(6) 2012.Revision due to infection.The case report form indicates the event is unlikely related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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