MAXFRAME 03.314.814SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982343734), received between Feb 19, 2026 and Feb 19, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 19, 2026Break; Device Slipped

  IT WAS REPORTED A POST-OPERATIVE EVENT OCCURRED INVOLVING A MAX FRAME SYSTEM INSTALLED ON A PATIENT'S LEG. DURING ROUTINE FOLLOW-UP, THE PATIENT REPORTED A PERCEIVED LOOSENING IN THE SYSTEM. UPON REVIEW OF AN IMAGE, THE SURGEON IDENTIFIED THAT STRUT NUMBER 4 HAD BROKEN. THE DEFECTIVE STRUT WAS REPLACED WITH A FUNCTIONAL ONE OF THE SAME CATALOG NUMBER. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED. THE COMPLAINT DEVICE STATUS IS NOT SPECIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390835 ↗