Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that a patient underwent a placement of a xtrafix device,at an unknown site.Subsequently, fourteen days later, the patient underwent a readjustment due to loss of position.No additional information is available.
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Manufacturer Narrative
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(b)(4).Report source: uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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