MAXFRAME 03.314.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982346872), received between Aug 5, 2025 and Jul 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Device Slipped; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024221 ↗
• MalfunctionMar 13, 2026Mechanical Problem

  IT WAS REPORTED THAT A MAXFRAME AUTOSTRUT HEAD UNIT WAS BEING UPLOADED WITH A REPLAN. DURING THE TESTING PROCESS OF THE INDIVIDUAL MOTORS, STRUT 1 WOULD NOT FUNCTION PROPERLY. THE MOTOR ON STRUT 1 WOULD TURN BUT IT WOULD KEEP TURNING CLOCKWISE FOR ABOUT 2-3 SECONDS. THE REST OF THE STRUTS ON THIS HEAD UNIT WOULD TURN CLOCKWISE, THEN COUNTERCLOCKWISE CORRECTLY. THEN WOULD GIVE THE APPROPRIATE ¿CHECK MARK¿ IN THE SOFTWARE PROGRAM. STRUT 1 HOWEVER, KEPT DOING AS PREVIOUSLY MENTIONED AND DID NOT GIVE THE CHECK MARK. A NEW HEAD UNIT WAS INSTALLED AND UPLOADED WITH THE REPLAN FOR THE PATIENT. ALL MOTORS FUNCTIONED PROPERLY AND THE CHECK MARKS APPEARED AS THEY WERE SUPPOSED TO PRIOR TO UPLOADING THE PROGRAM. THE PROGRAM WAS THEN UPLOADED AND STARTED. POST OP, THEY REPLANNED WITH THE EXISTING HEAD UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592815 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A WIRE OF THE HEAD UNIT SNAPPED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957876 ↗
• MalfunctionSep 23, 2025Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE WIRES WERE EXPOSED ON THE MAXFRAME CONTROL UNIT. HEAD UNIT WAS SHOWING AN ERROR, AND PATIENT CALLED WITH A CONCERN, MENTIONING EXPOSED WIRES. PATIENT CAME INTO CLINIC, ERROR WAS DETERMINED TO NOT BE BECAUSE OF THE EXPOSED WIRES (ANOTHER STRUT WAS STUCK). REPLACED THE HEAD UNIT FOR SAFETY CONCERNS AND TO HELP PREVENT A FUTURE ERROR. ISSUE WAS RESOLVED WITH INSTALLING A NEW CONTROL UNIT. THE PATIENT HAD DELAYED TREATMENT BY A COUPLE DAYS AND HAD TO MAKE A TRIP TO THE CLINIC, BUT HAD NO ADVERSE OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23120742 ↗
• MalfunctionAug 5, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MAXFRAME AUTOSTRUT WAS DAMAGED. THERE WAS SIGNIFICANT FRAYING OF THE RUBBER PROTECTIVE SLEEVE HOUSING THE ELECTRICAL WIRES ON THE DEVICE. THERE WAS ALSO A CRACK ON ONE OF THE MOTORS ON THE DEVICE. ADDITIONALLY, A DIAGNOSTIC TEST WAS RAN AN ISSUE WAS IDENTIFIED WITH THE MOTOR LABELED "4" THAT COULD HAVE POTENTIALLY THREW A RED LIGHT ON THE DEVICE AND RESTRICTED ANY FURTHER MOVEMENT OF THE FRAME. THE MOVEMENT CAPABILITIES OF THE MOTOR/STRUT WERE TESTED MANUALLY. HOWEVER, THERE SEEMED TO NOT BE AN ISSUE WITH THE MOTOR ITSELF AS THE DIAGNOSTIC TEST HAD ORIGINALLY CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719506 ↗