Catalog Number 6007-616-000 |
Device Problem
Imprecision (1307)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 12/18/2017 |
Event Type
malfunction
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Event Description
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It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the navigation device does not match the patient's actual outcome.The surgeon wanted to intentionally lengthen the operative leg by 3mm.Post operative x rays show the leg was actually lengthened by 8mm.The surgeon decided that no further revisions were necessary.There was no further medical intervention reported, or surgical delays.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the navigation device does not match the patient's actual outcome.The surgeon wanted to intentionally lengthen the operative leg by 3mm.Post operative x rays show the leg was actually lengthened by 8mm.The surgeon decided that no further revisions were necessary.There was no further medical intervention reported, or surgical delays.
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Search Alerts/Recalls
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