Model Number N/A |
Device Problem
Expulsion (2933)
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Patient Problem
No Information (3190)
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Event Date 07/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08571.
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Event Description
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It was reported that during am ankle syndesmosis repair procedure, upon tightening the button down to the plate, the juggerloc implant pulled out of the bone.The patient's bone was re-drilled and second kit was attempted to be implanted, but this anchor also pulled out of the bone.Surgery was successfully completed with competitor's screw.No additional patient consequences were reported.
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Manufacturer Narrative
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(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 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 event information available at the time of this report.
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Search Alerts/Recalls
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