M.U.S.T. Polyaxial Pedicle Screw 03.52.323Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030857584), received between Jul 31, 2018 and Sep 30, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture

  During revision surgery for an unknown cause, the screw fractured during extraction at the junction between the shaft and the screw head.

  Patient problems: Implant Pain

  MAUDE report 50946479 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  FEW DAYS AFTER THE PRIMARY LUMBAR FUSION WITH POSTERIOR SUPPLEMENTATION PERFORMED ON (B)(6) 2026, THE PATIENT DEVELOPED AN INFECTION. THE PATIENT RECEIVED TWO OTHER SURGERIES FOR SURGICAL CLEANING, ON (B)(6) 2026. NO DEVICES REVISED.

  Patient problems: Medical device site infection

  MAUDE report 25854818 ↗
• MalfunctionJul 9, 2024Fracture; Fracture

  PRIMARY SURGERY WAS PERFORMED AT L4-L5. ABOUT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON WANTED TO EXTEND THE CONSTRUCT IN L3. DURING SURGERY, THE SURGEON DISCOVERED THAT THE HEAD OF THE PEDICLE SCREW BROKE AT THE RIGHT SIDE OF L4. THE SURGEON REMOVED THE BROKEN SCREW AND REPLACED IT WITH A LARGER PEDICLE SCREW (7MM X 40MM). THE ISSUE CAUSED 15 MINUTES DELAY. XRAYS ARE NOT AVAILABLE. NO TRAUMATIC EVENT OCCURRED. PRIMARY SURGERY PERFOMED WITH MYSPINE TECHNOLOGY CASE CODE: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19701565 ↗
• InjuryMar 1, 2023Fracture; Fracture

  THE PATIENT CAME IN REPORTING PAIN DURING A POST-OP APPOINTMENT. THE SURGEON TOOK X-RAYS AND DECIDED TO SCHEDULE AN ADDITIONAL SURGERY AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY TO EXTEND THE PATIENT'S CONSTRUCT. DURING THE ADDITIONAL SURGERY, IT WAS OBSERVED THAT THE L5 MUST MC SCREW WAS BROKEN (TULIP HEAD CAME OFF). THE SURGEON COULD NOT REMOVE THE REST OF THE SCREW AND PROCEEDED TO EXTEND THE PATIENTS CONSTRUCT. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16459487 ↗
• InjuryMay 22, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A MYSPINE MC SURGERY IN (B)(6) 2020 AND WAS REVISED ONE DAY AFTER DUE TO PAIN, A CAGE HAS BEEN REMOVED. INITIALLY, A DECOMPRESSION WAS ON ONE SIDE, DURING THE REVISION SURGERY IT WAS DONE ALSO ON THE SECOND SIDE. ON (B)(6) OF 2020 THE PATIENT UNDERWENT REVISION SURGERY AGAIN DUE TO PEDICLE SCREWS LOOSENING. THE PATIENT HAS OSTEOPOROTIC BONE.

  Patient problems: Pain

  MAUDE report 10081873 ↗
• InjuryDec 13, 2019Appropriate Device Problem Term/Code Not Available

  1 MONTH POST PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SET SCREWS AND ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9465003 ↗
• InjuryNov 26, 2019Loose or Intermittent Connection

  THE ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM WAS INSERTED, BUT THE SCREW LOOSENING WAS CONFIRMED AFTER INSERTING THE SCREW COMPLETELY INTO THE BONE. ONE POSSIBLE REASON WAS THE PEDICLE SCREW THREAD WAS NOT FULLY DESIGNED NEAR THE PEDICLE SCREW TULIP, SO THE THREAD COULD NOT BE FIXED AT THE CORTICAL BONE COMPLETELY AND IT WAS NOT ABLE TO OBTAIN THE FIXING FORCE. PEDICLE SCREW WAS REPLACED WITH THE BACKUP PEDICLE SCREW. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. PATIENT BONE QUALITY WAS NOT GOOD.

  Patient problems: Failure of Implant

  MAUDE report 9374815 ↗
• MalfunctionNov 14, 2018Material Deformation; Material Deformation

  THE NURSE WAS NOT ABLE TO ENGAGE THE PEDICLE SCREW WITH THE SCREWDRIVER. AFTER MANY ATTEMPTS, DEBRIS WAS GENERATED ON THE PEDICLE SCREW THREAD. THE SURGERY WAS FINISHED WITH THE BACK UP IMPLANT. NO CRITICAL DELAY. THE SAME SCREWDRIVER WAS ABLE TO ENGAGE WITH THE BACK UP IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8069031 ↗
• MalfunctionSep 28, 2018Appropriate Device Problem Term/Code Not Available

  THE SURGEON WAS NOT ABLE TO TIGHTEN THE SET SCREW INTO THE PEDICLE SCREW TULIP AT L5 EVEN THOUGH THE HE USED WITH THE REDUCER. HE TRIED TO REMOVE THE ROD AND INSERT THE NEW SET SCREW, BUT HE WAS NOT ABLE TO TIGHTEN THE NEW SET SCREW AS WELL. DISASSEMBLING THE PERCUTANEOUS TOWER AND RE-TRYING AGAIN HE WAS ABLE TO TIGHTEN THE SECOND SET SCREW. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918477 ↗
• MalfunctionJul 31, 2018Difficult to Insert

  WHEN THE SURGEON WAS TRYING TO INSERT THE SET SCREW INTO THE PEDICLE SCREW HEAD WHICH WAS ALREADY IMPLANTED AT L5, IT WAS NOT ABLE TO INSERT, EVEN THOUGH THE SURGEON USED THE REDUCER. THEN HE TRIED TO INSERT WITHOUT THE ROD, BUT IT WAS NOT ABLE. SINCE IT WAS DOUBTFUL WHETHER THE ISSUE WAS WITH PEDICLE SCREW HEAD OR PERCUTANEOUS TOWER, THE PEDICLE SCREW WAS REPLACED WITH A MORE LARGE SIZE. THE SURGERY WAS PERFORMED BY PPS AND FINISHED SUCCESSFULLY. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734728 ↗