Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2019 - 02078.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.
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Event Description
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It was reported the anchor did not deploy and therefore could not be fully seated.No further information available at this time.
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Event Description
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No further information available at the time of this reporting.
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Manufacturer Narrative
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Udi: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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