Catalog Number 07.01702.005 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Failure of Implant (1924); Impaired Healing (2378)
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Event Type
Injury
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Event Description
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It was reported that the tulip heads of two virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.This is report one of two for this event.
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Manufacturer Narrative
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Corrections in b5.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Event Description
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It was reported that the tulip heads of three virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.This is report one of three for this event.
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Search Alerts/Recalls
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