Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2020-00517 to 3012447612-2020-00526.
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Reference reports 3012447612-2020-00517 to 3012447612-2020-00526.This follow-up report is being submitted to relay additional information.Information added to h6: component codes, health effect- impact code, health effect-clinical code, type of investigation, investigation findings, investigation conclusions summary: the complaint is confirmed for revision surgery due to pseudoarthrosis.Medical records were not provided for review.Device evaluation: product was not returned so a device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to patient conditions, traumatic event, or factors from the operation or product that were not provided by the complainant.Dhr review and related actions: dhr review could not be performed due to lack of lot information.No actions required.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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