MAXFRAME 03.312.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982261106), received between May 15, 2020 and Jan 3, 2024 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN (B)(6) 2023 THE MAXFRAME TENSIONER SLIPPED DURING TENSIONING. THE TENSIONER WAS REMOVED FROM THE PROCEDURE AND SET ASIDE FOR REVIEW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO GENERATION OF FRAGMENTS. THIS REPORT INVOLVES ONE (1) WIRE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433995 ↗
• MalfunctionNov 2, 2022Device Slipped; Mechanical Jam; Device Slipped; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2022 THEY WERE DOING A MAXFRAME WITH SURGEON. DURING THE CASE HAVING ISSUES WITH THE TENSIONERS IN THE SET. THEY KEPT PISTONING ON THE WIRE AND LOSING THEIR TENSION. THEY REACHED OUT AND THE ENGINEERS FOR MAXFRAME CALLED IN DURING THE CASE TO DISCUSS THE ISSUES. SURGEON HAD BEEN DOING FRAMES FOR YEARS. THEY WERE ABLE TO FINISH THE CASE AND GET OUT OF THE OR. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR A WIRE TENSIONER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716967 ↗
• MalfunctionNov 2, 2022Device Slipped; Mechanical Jam; Device Slipped; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6)2022 THEY WERE DOING A MAXFRAME WITH SURGEON. DURING THE CASE HAVING ISSUES WITH THE TENSIONERS IN THE SET. THEY KEPT PISTONING ON THE WIRE AND LOSING THEIR TENSION. THEY REACHED OUT AND THE ENGINEERS FOR MAXFRAME CALLED IN DURING THE CASE TO DISCUSS THE ISSUES. SURGEON HAD BEEN DOING FRAMES FOR YEARS. THEY WERE ABLE TO FINISH THE CASE AND GET OUT OF THE OR. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR A WIRE TENSIONER. THIS IS REPORT 3 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716954 ↗
• MalfunctionNov 2, 2022Device Slipped; Mechanical Jam; Device Slipped; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6)2022 THEY WERE DOING A MAXFRAME WITH SURGEON. DURING THE CASE HAVING ISSUES WITH THE TENSIONERS IN THE SET. THEY KEPT PISTONING ON THE WIRE AND LOSING THEIR TENSION. THEY REACHED OUT AND THE ENGINEERS FOR MAXFRAME CALLED IN DURING THE CASE TO DISCUSS THE ISSUES. SURGEON HAD BEEN DOING FRAMES FOR YEARS. THEY WERE ABLE TO FINISH THE CASE AND GET OUT OF THE OR. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR A WIRE TENSIONER. THIS IS REPORT 2 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716950 ↗
• MalfunctionJun 28, 2022Crack; Scratched Material; Crack; Scratched Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE WIRE TENSIONER WAS UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE WIRE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14845167 ↗
• MalfunctionMay 15, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, 2 WIRE TENSIONERS WERE NOT TENSIONING, THEY WERE NOT GRIPPING THE WIRE. THE FRAME CONSTRUCT HAD 8 WIRES TOTAL, AND 6 OF THEM WERE SUCCESSFULLY TENSIONED BUT THE REMAINING TWO WERE NOT. THE DOCTOR HAD GOTTEN THE WIRE TENSIONERS TO WORK AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2). THIS REPORT IS FOR 1 WIRE TENSIONER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063589 ↗
• MalfunctionMay 15, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, 2 WIRE TENSIONERS WERE NOT TENSIONING, THEY WERE NOT GRIPPING THE WIRE. THE FRAME CONSTRUCT HAD 8 WIRES TOTAL, AND 6 OF THEM WERE SUCCESSFULLY TENSIONED BUT THE REMAINING TWO WERE NOT. THE DOCTOR HAD GOTTEN THE WIRE TENSIONERS TO WORK AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2). THIS REPORT IS FOR 1 WIRE TENSIONER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063578 ↗