SynMesh 396.394Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034777504), received between Jun 25, 2021 and Jun 25, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN THE SKIN SUTURE, THE NEEDLE IS DISENGAGED FROM THE POLYPROPYLENE, TWO MORE SUTURES ARE REQUESTED WITH WHICH HAPPEN THE SAME. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR ONE (1) SYNMESH® IMPLANT HOLDER ANGLED. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068593 ↗
• MalfunctionJun 25, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN THE SKIN SUTURE, THE NEEDLE IS DISENGAGED FROM THE POLYPROPYLENE, TWO MORE SUTURES ARE REQUESTED WITH WHICH HAPPEN THE SAME. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SYNMESH® IMPLANT HOLDER ANGLED. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068589 ↗
• MalfunctionJun 25, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN THE SKIN SUTURE, THE NEEDLE IS DISENGAGED FROM THE POLYPROPYLENE, TWO MORE SUTURES ARE REQUESTED WITH WHICH HAPPEN THE SAME. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR ONE (1) SYNMESH® IMPLANT HOLDER ANGLED. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068587 ↗