Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Non Reproducible Results (4029)
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Patient Problems
Discomfort (2330); Injury (2348)
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Event Date 01/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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This pi is for the robot used in the primary surgery.As reported in pi (b)(4): patient underwent revision hip surgery for a one-time hip dislocation.Primary hip surgery done via mako on (b)(6) 2018.
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Event Description
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This pi is for the robot used in the primary surgery.As reported in (b)(4): patient underwent revision hip surgery for a one-time hip dislocation.Primary hip surgery done via mako on (b)(6) 2018.
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Manufacturer Narrative
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Reported event: an event regarding revision involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: not performed as the device being inspected is software.Rio serial number not reported.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 7 other reported event for the listed catalog number (b)(4).Conclusion: product inspection could not be completed due to no logs or session files not being available after 3 communications.
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Search Alerts/Recalls
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