MAXFRAME 1100010-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982338587), received between Feb 8, 2023 and Jan 23, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THERE WAS A BROKEN STRUT. NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218551 ↗
• MalfunctionOct 9, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AUTOSTRUT IN QUESTION BROKE AT THE CLEVIS. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. NO REVISION SURGERY WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT ¿ MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17894757 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE MEDIUM AUTOSTRUT BROKE AT THE CLAVICLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT ¿ MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17859560 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT CAME TO THE CLINIC WITH A BROKEN AUTOSTRUT. THE MED AUTOSTRUT BROKE AT THE SHOULDER BOLT INTERFACE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596404 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT ON JUNE 28, 2023, THE THREADS SNAPPED OFF THE DEVICE AND THE BALL SWIVEL FELL OUT. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MEDIUM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360780 ↗
• InjuryJul 6, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT STATED HE WAS SLIDING DOWN THE STAIRS TO GET TO THE MAIN FLOOR AND STRUT NUMBER 5 HAD BROKEN. THE PATIENT'S MOTHER STATED THAT DONTORIOUS BANGS THE STRUT ON EVERY STEP ON THE WAY DOWN. THE MOTHER ZIP-TIED THE STRUT TO THE RING, AND IT WAS BROKEN FOR A TOTAL OF TWO DAYS. THE SURGEON CHECKED THE STRUT LENGTHS OF ALL SIX STRUTS, AND THE PROGRAM HAD KEPT THEM WITHIN 1-2MM OF THE PLANNED ROBOTIC SCHEDULE. STRUT NUMBER 5, EVEN THOUGH IT HAD BROKEN TWO DAYS PRIOR TO THE STRUT CHANGE, WAS ALSO WITHIN THE 1-2MM DIFFERENCE, AND THE SURGEON FELT IT HAD NO NEGATIVE IMPACT ON PATIENT CARE. STRUT 5 WAS A MEDIUM STRUT, AND IT BROKE THROUGH THE SHOULDER BOLT KNUCKLE CONNECTION. THE PRODUCT IS AVAILABLE FOR RETURN. THE SCHEDULED STRUT CHANGE WAS SUCCESSFUL, AND NO HARM TO THE PATIENT WAS OBSERVED. STRUT 5 WAS A SCHEDULED STRUT CHANGE ON THIS DATE, AND IT WAS REPLACED WITH A LARGE AUTO STRUT. THIS ALSO NEEDED A NEW SHOULDER BOLT BECAUSE OF THE STRUT FAILURE, SO THEY WILL HAVE BOTH THE STRUT AND THE SHOULDER BOLT AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17270000 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT CAME INTO CLINIC WITH THREE BROKEN STRUTS. THE PATIENT CLAIMED THAT HE WAS SITTING BY SPACE HEATER WHEN THREE OF HIS MEDIUM AUTOSTRUTS CRACKED AT THE BASE OF BOLT CONNECTION. HE IS NOT BEARING ANY WEIGHT AND THIS IS THE SECOND OCCURRENCE OF THIS EVENT. PATIENT CLAIMED TO NOT BE TIGHTENING THE STRUTS HIMSELF. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265572 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT CAME INTO CLINIC WITH THREE BROKEN STRUTS. THE PATIENT CLAIMED THAT HE WAS SITTING BY SPACE HEATER WHEN THREE OF HIS MEDIUM AUTOSTRUTS CRACKED AT THE BASE OF BOLT CONNECTION. HE IS NOT BEARING ANY WEIGHT AND THIS IS THE SECOND OCCURRENCE OF THIS EVENT. PATIENT CLAIMED TO NOT BE TIGHTENING THE STRUTS HIMSELF. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265567 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT CAME INTO CLINIC WITH THREE BROKEN STRUTS. THE PATIENT CLAIMED THAT HE WAS SITTING BY SPACE HEATER WHEN THREE OF HIS MEDIUM AUTOSTRUTS CRACKED AT THE BASE OF BOLT CONNECTION. HE IS NOT BEARING ANY WEIGHT AND THIS IS THE SECOND OCCURRENCE OF THIS EVENT. PATIENT CLAIMED TO NOT BE TIGHTENING THE STRUTS HIMSELF. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261151 ↗
• MalfunctionFeb 8, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MEDIUM AUTO-STRUT BROKE AT PROXIMAL BALL JOINT AT OF END OF TREATMENT. THE STRUT BROKE A FEW DAYS BEFORE PLANNED REMOVAL. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328697 ↗