MAXFRAME 03.312.811Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982261021), received between Nov 2, 2018 and Sep 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 UPON STRUT TIGHTENING, THE THREADED ROD BROKEN AT THE LEVEL OF THE BALL JOINT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING. THE EVENT DID NOT OCCUR DURING FILED INSPECTION. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284856 ↗
• MalfunctionMar 29, 2023Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCT IN QUESTION WAS FOUND TO BE DAMAGED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXFRAME(TM) QUICK ADJUST STRUT/SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636856 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) MAXFRAME QUICK ADJUST STRUTS WERE FOUND TO BE BROKEN. IT IS UNKNOWN HOW OR WHEN THE BREAKAGE OCCURRED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A MAXFRAME(TM) QUICK ADJUST STRUT/SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8032739 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) MAXFRAME QUICK ADJUST STRUTS WERE FOUND TO BE BROKEN. IT IS UNKNOWN HOW OR WHEN THE BREAKAGE OCCURRED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A MAXFRAME(TM) QUICK ADJUST STRUT/SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8032666 ↗