According to the literature source of a study conducted between 2019 and 2022, a retrospective study evaluated outcomes in patients who underwent the standardized total extra-peritoneal technique.In some patients, a spacemaker dissection balloon was used to dissect the extra-peritoneal space.Dextile anatomical mesh (10x15) or a competitor mesh was placed without fixation to cover all potential hernia defects.There were 416 patients in the dextile group and 540 patients in the competitor group.Complications related to spacemaker included wound infection and delayed wound healing.Recurrences were due to either a lipoma or a true recurrence, requiring either surgical repair or conservative treatment.Antibiotics were necessary for infection, and prolonged hospitalization was reported.
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D10 concomitant products: dxt1510al, dextile dxt1510al 15x10cm left x1 (lot#unknown) dxt1510ar, dextile dxt1510ar 15x10cm right x1 (lot#unknown) reference: faessen, 2023, the first experience with the dextile anatomical mesh in laparoscopic inguinal hernia repair.Hernia.10.1007/s10029-023-02855-3 accepted: 27 july 2023.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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