Catalog Number UNK_OFL |
Device Problem
Insufficient Information (3190)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 10/20/2020 |
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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User feedback reported "during a lateral (size 1) partial knee procedure with version 3.0 software, doctor stated that burr damaged the it band and fat pad while burring the tibia." case type: not reported.
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection involving an unknown pka software was reported.The event was not confirmed.Method & results product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the alleged failure mode was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the log/session files, the primary operative report as well as follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
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Event Description
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User feedback reported "during a lateral (size 1) partial knee procedure with version 3.0 software, doctor stated that burr damaged the it band and fat pad while burring the tibia" case type : not reported.
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Search Alerts/Recalls
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