Model Number N/A |
Device Problems
Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Expiration date - ni.Manufacture date - ni.
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Event Description
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It was reported that a package of bone cement had a breached seal.No patient injury or delay in a procedure was reported as a result of the event.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Corrective actions have been initiated for the reported issue.
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Search Alerts/Recalls
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