Medicon 57.28.33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046826404338), received between Mar 4, 2026 and Apr 21, 2026 — classified as 3 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Appropriate Device Problem Term/Code Not Available

  DESCRIBE THE EVENT OR PROBLEM: FROM STAFF: WHILE PERFORMING PART OF THE PATIENT'S SPINAL SURGERY, THE TIP OF THE INSTRUMENT BEING USED (SPIKELESS KERRISON 3) BROKE OFF. NO EVIDENT HARM OCCURRED; THE BROKEN PIECE OF THE INSTRUMENT WAS EASILY RECOVERED FROM THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? T11 THROUGH L4 INSTRUMENTED POSTERIOR SPINAL FUSION WITH NAVIGATION. L2 LAMINECTOMY FOR DECOMPRESSION OF SPINAL CORD. USE OF NEURO MONITORING. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 24938171 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Bone Fracture(s)

  MAUDE report 24739835 ↗
• MalfunctionMar 4, 2026

  FROM STAFF: WHILE PERFORMING PART OF THE PATIENT'S SPINAL SURGERY, THE TIP OF THE INSTRUMENT BEING USED (SPIKELESS KERRISON 3) BROKE OFF. NO EVIDENT HARM OCCURRED; THE BROKEN PIECE OF THE INSTRUMENT WAS EASILY RECOVERED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505657 ↗