Device product code: qhp.Without a product return, no product evaluation is able to be conducted.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 3012447612-2021-00038 to 3012447612-2021-00056.
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Additional information in d4: expiration date and udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to surgical approach as mentioned by the surgeon.Dhr review: the dhr was reviewed; there are no indications of manufacturing issues that would have contributed to this event.Device use: this device is used for treatment.If additional information is received which changes the information in this report, a follow-up report will be submitted.
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