Catalog Number 110005090 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Udi (01) (b)(4).Foreign- the event occurred in (b)(6).The device remains in-vivo.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the device could not achieve correct tension without another device.The device was implanted without further issue.No further information.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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 as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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No further information is available at the time of this reporting.
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Search Alerts/Recalls
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