1.5MM SYSTEM - CRANIOCURVE (TM) MESH 01-9522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036153663), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K121624); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED THINNING OF THE OVERLYING SCALP APPROXIMATELY (1) ONE YEAR FOLLOWING IMPLANTATION OF A TITANIUM CRANIAL MESH PLATE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Skin Erosion

  MAUDE report 9996801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121624. One submission often covers many models, so check the product and lot details in each record.

• Z-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.