M.U.S.T. Midline Cortical (MC) Screw System 03.58.234Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971293465), received between Apr 25, 2025 and Jul 16, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  PLIF SURGERY WAS PERFORMED AT L3-L5 WITH THE MYSPINE MC GUIDE ON (B)(6) 2025. THE DAY AFTER THE SURGERY, CT SCAN WAS TAKEN AND IT APPEARED THAT THE ENTIRE GUIDE HAD BEEN PLACED TILTED TO THE LEFT (MEANING THAT THE TRAJECTORY OF THE SCREWS ARE VERY DIFFERENT FROM THE PLANNING). NO FITTING ISSUE WITH THE GUIDES WAS EXPERIENCED DURING SURGERY. THE PATIENT IS CURRENTLY ASYMPTOMATIC, AND THE SURGEON IS CURRENTLY WAITING FOR THE BONE FUSION. WEAK BONE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520976 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SPINAL FIXATION WAS PERFORMED AT L4-L5 WITH MYSPINE MC GUIDE. WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW (5.5MM X 40MM) AT RIGHT SIDE OF L5, THE PATIENT BONE BROKE. PATIENT'S BONE QUALITY WEAK. HOLE PREPARATION: 5MM UNDER TAP 6MM SAME TAP. THE SURGEON CHANGED THE TRAJECTORY AND INSERTED THE PEDICLE SCREW (5.5MM X 35MM). THE REASON FOR CHANGING THE SCREW LENGTH WAS THAT THE TRAJECTORY WAS CHANGED, RESULTING IN A SHORTER TRAJECTORY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21908585 ↗