Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/03/2014 |
Event Type
malfunction
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Event Description
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It was reported patient underwent a total elbow arthroplasty on (b)(6) 2014.During the procedure, it was noted the humeral trial was incorrectly marked.An implant of the same size as the trial was utilized to complete the procedure.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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Manufacturer Narrative
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Examination of returned device found evidence of product non-conformance.Corrective action has been initiated to address the reported issue.
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Search Alerts/Recalls
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