DISTRACTION, EXTERNAL 02-575-12-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118007803), received between Sep 18, 2020 and Sep 23, 2022 — classified as 2 injuries.

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.

• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PLACEMENT OF A RED DEVICE, A CRANIAL BONE FRACTURE WAS NOTED ADJACENT TO THE LOCATION OF A PIN USED TO SECURE THE DEVICE TO PATIENT'S SKULL. A CSF LEAK WAS NOTED AT THE FRACTURE SITE AND WAS SUCCESSFULLY CORRECTED DURING THE PROCEDURE. NO OTHER COMPLICATIONS WERE NOTED, AND THE DEVICE REMAINS IMPLANTED IN PATIENT AND IS PERFORMING AS EXPECTED. THE PHYSICIAN ADVISED THAT THE FRACTURE COULD HAVE HAPPENED REGARDLESS OF WHETHER A DIFFERENT DEVICE OR DIFFERENT TOOLS WERE USED IN THE PROCEDURE.

  Patient problems: Skull Fracture

  MAUDE report 15472914 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Impaired Healing

  MAUDE report 10553806 ↗