STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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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 09/25/2017 |
Event Type
malfunction
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Event Description
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It was reported to the sales representative that during a versatile hip navigation procedure, the surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides.It was alleged that after securing final implants, the navigation final reduction displayed 10mm long as intended.Post-operatively, it was reported that the patient¿s leg was lengthened by 2.5cm; the surgeon performed a revision surgery to shorten the leg by 1.5cm.It was reported that there was no further medical intervention reported, or surgical delays due to the revision.
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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 reported to the sales representative that during a versatile hip navigation procedure, the surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides.It was alleged that after securing final implants, the navigation final reduction displayed 10mm long as intended.Post-operatively, it was reported that the patient¿s leg was lengthened by 2.5cm; the surgeon performed a revision surgery to shorten the leg by 1.5cm.It was reported that there was no further medical intervention reported, or surgical delays due to the revision.
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Search Alerts/Recalls
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