Catalog Number 00392500200 |
Device Problem
Fracture (1260)
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Patient Problems
Weakness (2145); Brain Injury (2219); Alteration In Body Temperature (2682)
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Event Date 09/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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Event Description
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It was reported that during a procedure, the instrument fractured and damaged the patient's cauda equina.The patient was noted to have diminished strength.
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Manufacturer Narrative
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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.Device history record 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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