Catalog Number MSPL1015 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the gentrix surgical matrix plus (mspl1015) was implanted post expiry date.No patient injury was reported.Date of incident: (b)(6) 2022.Expiration date: october 31, 2021.
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Manufacturer Narrative
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Gentrix surgical matrix plus (mspl1015) was not returned for evaluation. dhr review - no anomaly specifically related to the compliant allegation is identified.Failure analysis - a complaint investigation and determination of root cause is not necessary as the device is within specification and did not fail.Expiration date was correctly printed on the device labeling.User failed to check the expiration date of the device before it was implanted in the patient.Root cause analysis - user erroneously implanted an expired device in patient.Expiration date was correctly printed on the device labeling.Device is within specification and did not fail.This is user error.
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Search Alerts/Recalls
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