M.U.S.T. Midline Cortical (MC) Screw System 03.58.264Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971293762), received between Apr 11, 2023 and Nov 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, THE PATIENT HAD PRIMARY SPINE SURGERY L3-L5. ON (B)(6) 2025, THE PATIENT REPORTED PAIN AND DURING REVISION SURGERY, THE SURGEON DISCOVERED THAT VERTEBRAL FUSION HAD FAILED AND 3 SCREWS WERE BROKEN. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN SCREWS AND REPLACE THEM. ALSO, CONSTRUCT WAS EXPANDED WITH A SCREW IN LEFT S1. THE SURGERY WAS COMPLETED SUCCESSFULLY ((B)(4)). PRESENTLY, ON (B)(6) 2025, THE SURGEON DETERMINED THE S1 SCREW WAS IMPLANTED TOO LOW AND NEEDED RE-ADJUSTMENT. THE SURGERY INVOLVED NO NEW MEDACTA IMPLANTS, BUT DID RESULT IN TAKING OUT THE SET SCREWS, THE ROD AND BACK OUT THE LEFT S1 SCREW TO RE-ADJUST ITS LOCATION AND THEN RE-IMPLANT THE SAME ROD AND SET SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669493 ↗
• InjuryApr 12, 2024Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  PRIMARY SURGERY WAS PERFORMED AT L4-S1.TLIF SURGERY. OPEN PROCEDURE. REVISION SURGERY WAS PERFORMED ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY AT L4-S2AI DUE TO SCREW BREAKAGE AT S1 LEFT (LOT 2321451), SCREW LOOSENING AT S1 RIGHT (LOT 2228101), AND THE BACK-OUT AND SINKING OF THE CAGE AT L5-S1. THE SURGEON REPLACED THE PEDICLE SCREW AT S1 LEFT (DIAMETER 7MM) WITH A SCREW OF DIAMETER 8MM, THE SCREW AT S1 RIGHT (DIAMETER 7MM) WITH A SCREW OF 10MM DIAMETER, AND THE CAGE WITH A COMPETITOR'S CAGE (HEIGHT 10 MM). PATIENT WITH PSEUDARTHROSIS. BONE QUALITY NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19097071 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING MYSPINE MC L5 SURGERY, AT THE END OF THE INSERTION OF THE SCREW, A BONE FRACTURE OCCURRED. THE SURGEON FELT HIGH RESISTANCE WHILE INSERTING THE SCREW. THE SCREW WAS IMPLANTED INTO THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT'S BONE QUALITY NORMAL. DIAMETER FOR THE TAPPING USED: 5MM AT FIRST, THEN 6MM, FINALLY 7 MM WAS USED.

  Patient problems: Bone Fracture(s)

  MAUDE report 16713623 ↗