M.U.S.T. Reduction Pedicle Screws 03.52.731Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030847226), received between Mar 8, 2019 and Sep 2, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN REPORTING PAIN AND NUMBNESS IN THE LEG. THE CAUSE OF THE NUMBNESS IN THE LEG IS UNKNOWN. ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DECIDED TO REMOVED THE 7X45 SCREW AND REPLACE IT WITH A 8X45 SCREW, CHANGING THE TRAJECTORY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Limb Pain

  MAUDE report 22936789 ↗
• MalfunctionMar 27, 2019Material Deformation; Material Deformation

  PLIF SURGERY PERFORMED AT L4-L5-S. THE SURGEON TRIED TO INSERT THE SET SCREW INTO THE REDUCTION CANNULATED PEDICLE SCREW TULIP AT LEFT SIDE OF L4, BUT THE HE WAS NOT ABLE TO INSERT IT COMPLETELY. THE SET SCREW SPINNED AROUND THE ROD. IT WAS DOUBTFUL THAT THE THREAD OF PEDICLE SCREW TULIP DEFORMED, SO THE SURGEON REPLACED THE REDUCTION PEDICLE SCREW WITH NEW STANDARD PEDICLE SCREW. AFTER THAT THE SURGEON ADJUSTED THE ROD BENDING AGAIN AND TRIED TO INSERT THE SET SCREW INTO THE REDUCTION CANNULATED PEDICLE SCREW TULIP AT LEFT SIDE OF S1, THE THREAD OF PEDICLE SCREW TULIP SEEMED TO BE DEFORMED WITH THE CROSS-THREADING. AFTER MANY ATTEMPTS WITH LOCKING TOWER, FINALLY HE WAS NOT ABLE TO INSERT THE SET SCREW, SO HE REPLACED PEDICLE SCREW WITH THE NEW ONE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8456539 ↗
• MalfunctionMar 8, 2019Solder Joint Fracture; Solder Joint Fracture

  SPINAL FIXATION PERFORMED AT L3-S2AI AND REDUCTION SCREWS WERE USED BETWEEN L3-L5. AFTER THE INSERTION OF REDUCTION SCREW AT L3 LEFT SIDE, IT WAS HARD TO DISENGAGE THE DRIVER FROM PEDICLE SCREW HEAD. FINALLY ONE TAB BROKE. THE SURGEON REPLACED THE BROKEN SCREW WITH A NEW ONE WITH THE SAME REFERENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8403889 ↗