MAXFRAME 03.312.180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982260826), received between May 9, 2018 and Aug 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2023Break; Break

  IT WAS FURTHER REPORTED THAT ORIGINAL MAXFRAME WAS PLACED ON (B)(6) 2022. NO PROGRAMMING WAS ADDED AT THIS STAGE FOR CORRECTION. SECOND STAGE MAXFRAME WAS ON (B)(6) 2023 ADDED FOOT SUPPORT KIT AND FURTHER DISTAL WIRE FIXATION. RAN TREATMENT PLAN FOR MAXFRAME AT THIS STAGE. THEN COMPLETED A STRUT SWAP EXCHANGE ON THE (B)(6) 2023 CONTINUING TREATMENT PLAN. THEN MAXFRAME FAILED ON THE (B)(6) 2023 AS DESCRIBED AND REMOVED AND LAST OPERATION OCCURRED ON THE (B)(6) 2023 WHERE PATIENT WAS REVISED WITH A TIBIAL NAIL ADVANCED. IT IS CONFIRMED THAT NONE OF THE ORIGINAL COMPONENTS OF MAXFRAME WERE REMOVED/REVISED UP UNTIL THE (B)(6) 2023. THE PATIENT TIMELINE REFLECTS PROCEDURES TO FURTHER THE PROGRESS OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17630641 ↗
• InjuryMay 9, 2018Break; Crack; Break; Crack

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE MAXFRAME FULL RING 180MM ON UNKNOWN DATE. IT WAS NOTED ON UNKNOWN DATE THAT THE DEVICE HAD CRACKED. SURGEON USED A DISTRACTION OSTEOGENESIS (DO) SYSTEM AND ATTACHED A DO HALF RING TO THE BROKEN MAXFRAME FULL RING VIA FIVE (5) THREADED RODS AND TWENTY (20) NUTS. THE HALF RING SPANNED THE CRACK IN THE MAXFRAME FULL RING TO PROVIDE STABILITY TO THE FRAME. THE ENTIRE FRAME WILL BE REMOVED AS PREVIOUSLY SCHEDULED. THIS REPORT IS FOR ONE (1) MAXFRAME FULL RING 180MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7501318 ↗