Catalog Number 4193 |
Device Problems
Defective Device (2588); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not 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 product didn't work.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The returned device was evaluated and the event was not confirmed.The product works as intended.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It has been reported that the product didn't work.
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Search Alerts/Recalls
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