Model Number N/A |
Device Problems
Infusion or Flow Problem (2964); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Unique device identifier: (b)(4).Report source- foreign.The event occurred in (b)(6).Pma 510(k): - the product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the monomer liquid could not enter the cartridge.No further information has been made available at this time.
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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 as the product was not returned.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause of the event cannot 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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Event Description
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It has been reported that the monomer liquid could not enter the cartridge.No further information has been made available at this time.
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Search Alerts/Recalls
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