Catalog Number 111640 |
Device Problems
Output Problem (3005); Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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As part of the 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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Femur fracture at pin site.Update 24/october/2019 as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins.".
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Event Description
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Femur fracture at pin site.Update 24/october/2019 wg: as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins.".
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Manufacturer Narrative
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Follow-up #1 and final report submitted to update based on the results of investigation.Femur fracture at pin site.Update 24/october/2019 wg: as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins." product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿if additional information is received then the complaint will be reopened.
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Search Alerts/Recalls
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