NA 421.535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587050690), received between Nov 28, 2023 and Jan 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LEFT SIDE OF THE MESH WAS BROKEN. IN (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL FOR EXAMINATION. THE IMAGING EXAMINATION SHOWED SLIGHT CRACK OF TITANIUM MESH ON THE OTHER SIDE, WITHOUT DISPLACEMENT OR OTHER ABNORMALITIES. THE SECOND OPERATION TO REMOVE THE BROKEN MESH WAS ON (B)(6), 2023.

  Patient problems: Insufficient Information

  MAUDE report 18534399 ↗
• MalfunctionNov 28, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE, DUE TO A BROKEN TITANIUM MESH. A NEW MESH WAS IMPLANTED. THE PATIENT UNDERWENT CRANIOPLASTY WITH TITANIUM MESH IMPLANTATION ON (B)(6) 2018. ON (B)(6) 2023, A CT REEXAMINATION REVEALED A FRACTURE IN THE TITANIUM MESH. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THIS REPORT IS FOR A TI LOW PROF NEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220848 ↗