Catalog Number 01 046 02 |
Device Problems
Image Display Error/Artifact (1304); Incorrect Measurement (1383)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/30/2019 |
Event Type
malfunction
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Event Description
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It was reported that the navigation of the universal tracker was opened during a case and was inaccurate during a procedure.The possible harm associated with a reported event of inaccuracy during a procedure is a revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : device discarded.
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Event Description
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It was reported that the navigation of the universal tracker was opened during a case and was inaccurate during a procedure.The possible harm associated with a reported event of inaccuracy during a procedure is a revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
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Search Alerts/Recalls
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