M.U.S.T. Midline Cortical (MC) Screw System 03.58.243Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971293557), received between Sep 8, 2023 and Sep 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2023Positioning Failure; Difficult to Insert; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Difficult to Insert; Appropriate Device Problem Term/Code Not Available

  THE SURGERY WAS CONDUCTED ON L4-L5 TLIF. THE SCREW WAS INSERTED BY USING A COMPETITOR GUIDE PIN (Ø 1.5MM) AFTER THE PREPARATION OF SCREW TRAJECTORY BY USING MYSPINE MC DRILL-BASED GUIDE L04. IT HAS BEEN OBSERVED THAT THE SCREW TRAJECTORY DEVIATED MEDIALLY FROM THE PLANNED ONE AND A DIFFERENT TRAJECTORY WAS MADE BY FREEHAND. IT HAS BEEN REPORTED THAT THE DRILLED LEFT L04 TRAJECTORY WAS FINE AND IT WAS NOT DEVIATED BEFORE THE GUIDE PIN INSERTION. MOREOVER, THE L04 ENTRY POINT HAS BEEN PREPARED ACCORDING TO THE SKIVING WARNING ON THE PLANNING. ISSUE DETECTED ONLY AT L04 LEVEL. A NEW SCREW (SAME REFERENCE AND LOT) WAS IMPLANTED. IT WAS NOT POSSIBLE TO IMPLANT THE MUST MC CROSS-CONNECTOR 27-40MM ADJUSTABLE BECAUSE IT WAS BEYOND THE CONNECTOR ANGULAR RANGE. THE PATIENT BONE QUALITY WAS HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME WAS 30MIN AND TOTAL TIME OF THE SURGERY WAS 3H.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710244 ↗