Catalog Number 3910-100-015 |
Device Problems
Device Expiration Issue (1216); Expiration Date Error (2528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that an expired anchor was implanted into a patient.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: expired anchor.Probable root cause: design.Validated shelf life too short.Application distribution inefficient, sat too long in inventory before being shipped to customer.The failure mode will be monitored for future reoccurrence.Mfg date: 03/05/2014.(b)(4).
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Event Description
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It was reported that an expired anchor was implanted into a patient.
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Search Alerts/Recalls
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