Catalog Number 61910002 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.
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Event Description
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During surgery, simplex were hardening early.The cement was not pushed out from the cement gun.The surgeon used the cementless implant and finished the surgery.
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Manufacturer Narrative
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Additional information, update to section initial reporter address and initial reporter city.
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Event Description
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During surgery, simplex were hardening early.The cement was not pushed out from the cement gun.The surgeon used the cementless implant and finished the surgery.
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Search Alerts/Recalls
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