MAXFRAME 1100012-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982338594), received between May 19, 2023 and Aug 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE IN 2023, THAT THE SURGEON WAS PROGRAMMING THE AUTOSTRUT HEAD UNIT. MOTOR NUMBER 3 WOULD NOT PASS THE INITIAL TEST IN THE FIRST SCREEN IN THE SOFTWARE. THE SURGEON WAS ADVISED TO CHECK THE MOTOR CLIP TO MAKE SURE THE MOTOR WAS SITTING IN THE STRUT APPROPRIATELY, HE CONFIRMED IT WAS. HE THEN RAN MANUAL MODE FORWARD AND BACKWARDS ONE TIME TO SEE IF THE MOTOR WAS TURNING THE GEAR IN THE STRUT. IT WAS CONFIRMED THE MOTOR WAS LIGHTING UP GREEN AND IT MOVED. HE THEN TESTED AGAIN, BUT THE STRUT DID NOT PASS. HE REPLACED THE SHORT STRUT TO SEE IF THE STRUT WAS THE ISSUE, BUT IT STILL WAS NOT PASSING THE INITIAL TEST. THE MOTOR WAS REMOVED AND USED THE BLUE KNOB TO BE SURE THERE WAS NOT TOO MUCH TENSION ON THE STRUT. CONFIRMED THERE WAS NOT TOO MUCH TENSION. THE SURGEON THEN USED MOTOR NUMBER 4 IN STRUT NUMBER 3 DURING THE TEST TO SEE IF IT COULD PASS, AND IT DID. IT WAS ADVISED AT THAT TIME TO REPLACE THE HEAD UNIT. THE NEW HEAD UNIT WAS APPLIED AND LOADING OF THE PROGRAM PASSED AND WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - SHORTTHIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573738 ↗
• MalfunctionMay 23, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2023 THE MAX-FRAME STRUTS WERE NOT MOVING APPROPRIATELY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983253 ↗
• MalfunctionMay 19, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6)2023 THE MAX-FRAME STRUTS WERE NOT MOVING APPROPRIATELY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968788 ↗
• MalfunctionMay 19, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON MAY 4.2023 THE MAX-FRAME STRUTS WERE NOT MOVING APPROPRIATELY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968649 ↗