Reference: (b)(4).Catalog # 00-1003-4001, lot # m59112-b, quantity of 5.Complaint sample was returned for evaluation.Reported event was confirmed.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00082, 3006460612-2019-00083, 3006460612-2020-00015.
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