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 3003853072-2020-00008 to 3003853072-2020-00020 and 3012447612-2020-00158.
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Additional information in b4, g4, g7, h2, h6: methods, results, and conclusion codes.The product was not returned and no photos were provided, so an evaluation is unable to be performed.The lot number was not provided and a device history review cannot be conducted.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Provided x-rays demonstrate the recurrence of the spondylolisthesis.The complaint is confirmed.A definitive root cause cannot be determined.
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