Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 09/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that before surgery, the doctor opened the bone cement and found that the powder was leaking out and the aseptic packing bag was not sealed.
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Event Description
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It has been reported that before surgery, the doctor opened the bone cement and found that the powder was leaking out, and the aseptic packing bag was not sealed.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Corrective action has been initiated for the reported issue.The device was not returned to the manufacturer.Therefore it was not analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended, however investigation showed that the most probable cause of the event was related to maufacturing.Corrective action has been initiated to address reported issue.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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Search Alerts/Recalls
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