NA 286004103Recalls & reported problems
Medos International Sàrl · Kerrison 40 degree 3mm · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034548791), received between May 17, 2024 and May 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2024Break; Break
IT WAS REPORTED THAT ON APRIL 22, 2024, CUSTOMER REPORTED THE SYSTEM CONTINUING TO FREEZE UP AND LOCK UP ON THE SCREENS. THE ISSUE OBSERVED RIGHT AFTER INSTALLATION. A BROKEN INSTRUMENT WAS FOUND WHILE CHECKING ITEMS FROM THE INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NEXT DAY OF SURGERY, (B)(6) 2024. ALL INFORMATION HAS BEEN DISCLOSED. THIS REPORT IS FOR ONE (1) KERRISON, 40 DEG, 3MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19343329 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.