M.U.S.T. Polyaxial Pedicle Screw 03.52.322Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030857577), received between Sep 19, 2019 and May 25, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO HAVING TWO LOOSE SCREWS ON THE BOTTOM OF THE SPINE CONSTRUCT AND THE CAUSE IS UNKNOWN. THERE IS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE 40MM RODS TO 35MM RODS AND REVISED THE TWO 6X35MM PEDICLE SCREWS TO 8X40MM PEDICLE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25268619 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 MONTHS POST PRIMARY THE SURGEON OBSERVED THAT THE SCREWS WERE LOOSE DUE TO THE INFECTION. THE SURGEON REVISED THE SCREWS AND THE RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Medical device site infection

  MAUDE report 23510664 ↗
• InjuryNov 22, 2023Fracture; Fracture

  AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND ONE OF THE SIX SCREWS WAS OBSERVED TO BE BROKEN AT THE BOTTOM OF THE CONSTRUCT. IT IS UNKNOWN HOW/WHY THIS OCCURRED. A REVISION SURGERY HAS NOT BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191989 ↗
• InjuryJul 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  L4/5 PLIF PRIMARY SURGERY WAS CONDUCTED WITH COMPETITOR'S PRODUCTS IN 2013. DURING REVISION SURGERY OF COMPETITOR'S IMPLANT (5.5MM SCREWS) DUE TO ADJACENT INTERVERTEBRAL OBSTRUCTION, AFTER INSERTION OF 6X35MM SCREW IN LEFT SIDE AND 6X40MM SCREW IN RIGHT SIDE, PATIENT'S VERTEBRAE FRACTURE WAS NOTICED. BOTH OF SCREWS IN RIGHT AND LEFT SIDE WERE REMOVED. THE CAUSE OF FRACTURE WAS UNKNOWN. 6MM TAPPING WAS PERFORMED IN L5 RIGHT AND LEFT. THE SURGEON TRIED TO INSERT NEW 6X30MM SCREW IN L5 RIGHT SIDE, BUT THE BLEEDING OCCURRED AND THE SCREW WAS REMOVED. NO SCREW WAS IMPLANTED IN BOTH SIDE OF L5, A ROD WAS IMPLANTED BETWEEN L3/4 ONLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17403723 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  L4/5 FIXATION SURGERY. THE PATIENT'S PEDICLES ON L4 BROKE DURING SCREW INSERTION. LARGER SIZE SCREWS WAS USED TO COMPLETE THE SURGERY. THE SURGEON DRILL THE HOLE, THEN 5 MM TAPPING AND 6 MM TAPPING. K-WIRE WAS USED. BONE QUALITY NORMAL. NO SKIVING PROBLEM OCCURRED DURING INSERTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 16021055 ↗
• InjuryAug 5, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE TOP RIGHT SIDE SCREW (L4) WAS DISPLACED LATERALLY ABOUT A WEEK POST-PRIMARY. THE SURGEON REVISED 2 SCREWS AND THE ROD (6X35 SCREWS AND 35MM ROD). THE SURGEON SUSPECTS POOR BONE QUALITY AS THE REASON. THE SCREW WAS INITIALLY WELL PLACED USING THE MYSPINE DRILL GUIDES.

  Patient problems: Insufficient Information

  MAUDE report 15174142 ↗
• InjuryJul 8, 2021Fracture

  1 WEEK AFTER THE PRIMARY MYSPINE SURGERY A S1 BONE FRACTURE LINE WAS DETECTED THROUGH THE CT. NO ADDITIONAL SURGERY PLANNED AT THE MOMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12133767 ↗
• InjurySep 19, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PRIMARY SURGERY PERFORMED AT L4-L5-S1 ON AUGUST 1. REVISION SURGERY PERFORMED ON AUGUST 20 DUE TO THE PEDICLE SCREW LOOSENING AT BOTH OF L4. THE REASON OF THE LOOSENING WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086487 ↗