Model Number 209999 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/14/2020 |
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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This pi is for the robot used in the primary surgery.It was reported that the patient's right lateral pka was revised due to infection.All components were removed and a spacer was placed.Rep provided the revision usage sheet and confirmed that no further information is available from the hospital or surgeon.
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Manufacturer Narrative
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Update to d2.Reported event: it was reported ¿this pi is for the robot used in the primary surgery.It was reported that the patient's right lateral pka was revised due to infection.All components were removed and a spacer was placed.Rep provided the revision usage sheet and confirmed that no further information is available from the hospital or surgeon.¿ 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: review of the device history records associated with rob762 indicate that on 19/07/2018 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for pka software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Event Description
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This pi is for the robot used in the primary surgery.It was reported that the patient's right lateral pka was revised due to infection.All components were removed and a spacer was placed.Rep provided the revision usage sheet and confirmed that no further information is available from the hospital or surgeon.
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Search Alerts/Recalls
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