M.U.S.T. Polyaxial Pedicle Screw 03.52.324Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030857591), received between Sep 21, 2018 and Mar 2, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Fracture

  AT 1 YEAR AND 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND THE CAUSE WAS DETERMINED TO BE A BROKEN SCREW. THE SURGEON SUSPECTED LOOSENING OF THE SCREWS, BUT FOUND ONE HAD COMPLETELY BROKEN AT THE L5 LOCATION. NO INDICATIONS OF TRAUMA WERE PRESENT. THE SURGEON REVISED THE RODS AND ALL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. BONE QUALITY REPORTED TO BE NORMAL.

  Patient problems: Implant Pain

  MAUDE report 24481993 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LOWER EDGE OF THE PEDICLE ON BOTH SIDES OF L5 FRACTURED DURING SCREW INSERTION IN THE CORTICAL BONE TRAJECTORY. ON THE LEFT, THE LOWER EDGE OF THE PEDICLE WAS SLIGHTLY CRACKED, AND ON THE RIGHT, THE ENTIRE LOWER EDGE OF THE PEDICLE WAS CRACKED. BONE QUALITY WAS NORMAL. THE SURGEON USED MYSPINEMC GUIDE. HE DID A 5MM UNDER DRILL, THEN A 5MM TAP WITH A GUIDE WIRE, AND THEN A 6 MM TAP. ONE SIDE STILL SEEMED TO BE FIXED, SO THE SCREW WAS LEFT AS IT WAS. THE FRACTURE ON THE OTHER SIDE WAS LARGE AND THE LARGER SCREW WAS INSERTED INTO THE PEDICLE SCREW TRAJECTORY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15664975 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated

  SPINAL FIXTAION WAS PERFORMED AT L4-L5 BY PPS INITIALLY. WHEN THE SURGEON TRIED TO PERFORM THE REDUCTION AT THE BOTH SIDE OF L4, THE BOTH SIDE OF PEDICLE SCREWS WERE PULLED OUT FROM THE PATIENT BONE. THE SURGEON REMOVED THE PEDICLE SCREWS AT THE BOTH SIDE OF L4, AND INSERTED THE PEDICLE SCREWS WHICH WERE REMOVED FROM THE L4 AT THE BOTH SIDE OF L3. THE SURGEON INSERTED THE MORE LARGER SIZE PEDICLE SCREWS AT L4 AND REPLACED 2 RODS. FINALLY, L3-L5 WAS FIXED. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. TOTAL SURGERY TIME WAS ABOUT 3 HOURS. THE SURGEON EXPRESSED AN OPINION THAT THE SELECTION OF THE PEDICLE SCREW SIZE WAS CORRECT. THE FIXATION STRENGTH OF 6MM SCREW SEEMED TO BE LESS EFFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10349976 ↗
• InjurySep 21, 2018Break; Break

  THE SURGEON DETECTED THAT 2 SCREWS BROKE INSIDE THE PATIENT AND HE PLANS TO REVISE THE COMPONENTS ON (B)(6) 2018.

  Patient problems: Foreign Body In Patient

  MAUDE report 7897536 ↗