Disposable Cranial Perforator 200-271 14/11 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810607000071), received between Jun 23, 2026 and Jun 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Auto Stop” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Failure to Auto Stop

  THE PERFORATOR DID NOT STOP. IT WAS THE FIRST DRILL HOLE MADE WITH THE PERFORATOR. IT WAS IN THE TEMPORAL LOBE. THE DRILL BIT DIDN'T STOP AND SIMPLY FELL THROUGH THE BONE, PERFORATING THE DURA MATTER AND CAUSING A CONTUSION IN THE TEMPORAL LOBE. THE HOSPITAL REPORTED NO DEATH OR SERIOUS INJURY HAS OCCURED DUE TO THIS EVENT.

  Patient problems: Bruise/Contusion

  MAUDE report 25598579 ↗