Catalog Number 6188-1-001 |
Device Problem
Shelf Life Exceeded (1567)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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It was reported to the sales rep by the o.R.Supervisor that expired bone cement was implanted in the patient.Simplex used expired in 2013.
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Manufacturer Narrative
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Conclusion: an event regarding usage of expired product involving simplex p half dose bone cement was reported.A review of the packaging label of the reported product indicates an expiry date of 2013-09 (september 2013).This product was reportedly used in surgery on (b)(6)-2015.It is the responsibility of the user to verify the expiration date and ensure that the product is used within this time frame.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported to the sales rep by the o.R.Supervisor that expired bone cement was implanted in the patient.Simplex used expired in 2013.
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Search Alerts/Recalls
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