M.U.S.T. Polyaxial Pedicle Screw 03.52.339Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030857775), received between Feb 22, 2018 and Dec 6, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 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.

• InjuryDec 6, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN AND THE SURGEON STATED HE WAS DISPLEASED WITH THE SCREW PLACEMENT. A 7X50MM SCREW WAS REMOVED AND REPLACED WITH A 6X50MM SCREW AFTER ABOUT 1 MONTH FROM THE PRIMARY. THE SURGEON DIDN'T USE THE MYSPINE GUIDES IN PRIMARY.

  Patient problems: Pain

  MAUDE report 8137078 ↗
• MalfunctionNov 26, 2018Break; Material Deformation; Break; Material Deformation

  REVISION SURGERY PERFORMED TO FIX L2/L5. WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW AT L5, THE TIP OF THE SCREWDRIVER BROKE. HE REPLACED THE SET SCREW WITH A NEW ONE, BUT THE BROKEN PIECES OF THE SCREWDRIVER REMAINED AT THE PEDICLE SCREW AND HE WAS NOT ABLE TO INSERT THE SET SCREW. THE THREAD OF THE PEDICLE SCREW HEAD AT L5 MIGHT BE DEFORMED AT THAT TIME. DUE TO THESE REASONS, HE WAS NOT ABLE TO REPLACE THE PEDICLE SCREW AT L5 AND THE SURGERY FINISHED WITH FIXING L2/L4. DUE TO THIS EVENT THE SURGERY WAS PROLONGED FOR ABOUT 1 HOUR AND THE PATIENT WOULD REQUIRE LONGER REHABILITATION THAN EXPECTED. DUE TO THE FACT THE SURGEON WAS NOT ABLE TO RETRIEVE ALL THE BROKEN PIECES, SOME PIECES WOULD BE STILL REMAINING IN THE PATIENT BODY. ONLY THE BROKEN INSTRUMENT IS AVAILABLE FOR THE INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 8101389 ↗
• MalfunctionFeb 22, 2018Bent; Break

  SURGEON WAS NOT ABLE TO TIGHTEN THE 4TH SET SCREW (HEX). PERCUTANEOUS TOWER INNER SLEEVE HAS BEEN BENT, TULIP AND SET SCREW THREAD WAS DAMAGED. AFTER A LOT OF TRIES AND NEW ATTEMPTS, SURGEON CHANGED THE SET SCREW AGAIN TWO NEW ONES. WITHOUT ANY SUCCESS. SO HE DECIDES TO REMOVE THE SCREW AND SET SCREW AND CHANGED IT AGAIN WITH A NEW ONE, INCLUDING A TORX SET SCREW INSTEAD OF THE HEX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288847 ↗