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3DMAX 0116320Recalls & reported problems

Davol Inc. · 3DMax MID Anatomical Mesh, 8 cm x 13 cm (3" x 5"), Medium, Right · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741200779), received between Aug 21, 2023 and Aug 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    AS REPORTED, DURING A ROBOTIC PROCEDURE, WHILE ROLLING THE 3DMAX MID MESH IN PREPARATION TO PLACE THROUGH AN 8MM TROCAR, THE SURGEON FOUND CRACKING OF THE SEALED EDGE OF THE DEVICE. IT WAS REPORTED THAT EDGE OF THE MESH WAS BRITTLE AND PEELING OFF. IT WAS REPORTED THAT THE SAME ISSUE PERSISTED IN MULTIPLE DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3DMAX MID MESH WHICH DID NOT CRACK. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17588752 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.