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
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/19/2018 |
Event Type
malfunction
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Event Description
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It was reported by the user facility that after a navigation hip case, there was an inaccuracy of 9mm from what was shown during the procedure by the navigation system, and what was determined x rays after the procedure.An inaccuracy by the device can create a risk of large prosthesis misalignment during procedures.There was no medical intervention, known adverse consequences to the patient, or surgical delays due to the procedure.
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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 by the user facility that after a navigation hip case, there was an inaccuracy of 9mm from what was shown during the procedure by the navigation system, and what was determined x rays after the procedure.An inaccuracy by the device can create a risk of large prosthesis misalignment during procedures.There was no medical intervention, known adverse consequences to the patient, or surgical delays due to the procedure.
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Search Alerts/Recalls
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