Burr Hole Cover 8110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855547005205), received between Mar 15, 2018 and Nov 18, 2020 — classified as 1 injury, 1 malfunction.

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

• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INCISION SITE OVER ONE OF THE NEUROPACE BURR HOLE COVERS DID NOT PROPERLY HEAL. THE TREATING CLINICIAN NOTED THAT THE PATIENT'S SKIN WAS VERY THIN OVERLYING THE BURR HOLE, AND LOCAL WOUND CARE (ORAL ANTIBIOTICS, MEDIHONEY, PEROXIDE, ETC.) WERE NOT EFFECTIVE IN THE HEALING PROCESS. THE BURR HOLE COVER WAS EXPLANTED AND REPLACED WITH A BURR HOLE PLATE (NON-NEUROPACE MANUFACTURED PRODUCT). ADDITIONAL TREATMENT INCLUDED ORAL ANTIBIOTICS.

  Patient problems: Impaired Healing

  MAUDE report 10861612 ↗
• MalfunctionMar 15, 2018Shelf Life Exceeded; Shelf Life Exceeded

  WHEN PROCESSING PRODUCT REGISTRATION INFORMATION, NEUROPACE BECAME AWARE THAT ONE OF THE BURR HOLE COVERS IMPLANTED ON (B)(6) 2018 WAS EXPIRED AT THE TIME OF USE. THE PRODUCT EXPIRED ON 1/26/2018. NEUROPACE IMMEDIATELY INFORMED THE TREATING CENTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342138 ↗