MAXFRAME 1100007-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982338600), received between Mar 13, 2023 and May 12, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Crack; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MAXFRAME AUTOSTRUT HEAD UNIT SHOWED ORANGE AND RED LIGHT. SEEMED TO BE THAT THE STOP BUTTON WAS PUSHED. WHEN WE WENT TO REPROGRAM THE HEADUNIT, IT WOULD NOT PASS THE SCREEN "STOP BUTTON PUSHED, PLEASE PRESS THE STOP BUTTON AGAIN TO CONTINUE". THEY DID THAT MULTIPLE TIMES WHILE EXITING OUT OF THE APP ON THE LAPTOP AND TRYING AGAIN. THEN THEY RESET THE HEAD UNIT, AND STILL NO HELP. THEY NOTICED THERE WAS A FRAY IN THE WIRE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003226 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT POSTOPERATIVELY, THE PATIENT CAUGHT THE CORD OF THE DEVICE ON HER WALKER AND SEVERED THE CORD. THE UNIT WENT RED AND STOPPED WORKING.

  Patient problems: Insufficient Information

  MAUDE report 21118089 ↗
• MalfunctionNov 5, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024 THE AUTOSTRUT CONTAINED EXPOSED WIRES ON ONE OF THE MOTORS. THERE WAS NO INVOLVEMENT OF ANY OPERATION AND PATIENT. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609408 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE LOCK IN THE SET BROKE. THIS REPORT INVOLVES ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20024593 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 18, 2024, ONE OF THE GEAR LOCKS ON A MAXFRAME HEXAPOD KIT BROKE. THERE WAS NO MEDICAL INTERVENTION. THE PATIENT REPLACED THE GEAR LOCKS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994911 ↗
• 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 CRLSYS KIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573731 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875135 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875134 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875131 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875130 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875129 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875127 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN REMOVING THE AUTOSTRUT MOTORS AND PUTTING GEAR LOCKERS ONTO THE STRUTS, SEVERAL OF THEM BROKE INTO MULTIPLE PIECES. 12 TOTAL GEAR LOCKERS WERE TAKEN FROM 2 PACKAGES, AND 7 OF THEM BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875126 ↗
• MalfunctionMar 13, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT AUTOSTRUT HEAD UNIT WAS MALFUNCTIONING. STRUT #5 MALFUNCTION. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528733 ↗