M.U.S.T. Pedicle Screw SystemRecalls & reported problems across all models
Medacta International SA · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 1
- Injuries reported
- 17
- Recalls
- 0
We found 20 models of M.U.S.T. Pedicle Screw System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2021 and Feb 26, 2026 — classified as 1 death, 17 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Migration” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported M.U.S.T. Pedicle Screw System problems
Device problems
- Migration7
- Adverse Event Without Identified Device or Use Problem5
- Fracture4
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Failure to Advance1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information3
- Bone Fracture(s)2
- Hemorrhage/Blood Loss/Bleeding2
- Implant Pain2
- Failure of Implant1
- Inadequate Osseointegration1
M.U.S.T. Pedicle Screw System models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M.U.S.T. Pedicle Screw System 03.61.324Bone Cement, Posterior Screw Augmentation2 reports
- M.U.S.T. Pedicle Screw System 03.57.024Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Pedicle Screw System 03.57.033Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Pedicle Screw System 03.57.035Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Pedicle Screw System 03.57.044Appliance, Fixation, Spinal Intervertebral Body1 death2 reports
- M.U.S.T. Pedicle Screw System 03.59.225Appliance, Fixation, Spinal Intervertebral Body2 reports
- M.U.S.T. Pedicle Screw System 03.61.323Bone Cement, Posterior Screw Augmentation1 report
- M.U.S.T. Pedicle Screw System 03.61.338Bone Cement, Posterior Screw Augmentation1 report
- M.U.S.T. Pedicle Screw System 03.56.503Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.56.106Appliance, Fixation, Spinal Interlaminal1 report
- M.U.S.T. Pedicle Screw System 03.68.380Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.68.381Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.68.391Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.68.921Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.57.002Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.57.012Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.57.023Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.57.025Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Pedicle Screw System 03.59.025Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Pedicle Screw System 03.59.234Appliance, Fixation, Spinal Intervertebral Body1 report
Recent M.U.S.T. Pedicle Screw System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Fracture
PRIMARY SURGERY PERFORMED ON (B)(6) 2022. SINGLE-SEGMENT SPONDYLODESIS L4-5 WITH MYSPINE MC, MUST + MECTALIF OBLIQUE. FIRST REVISION SURGERYPERFORMED ON (B)(6) 2022 DUE TO VENTRAL CAGE MIGRATION (MDR (B)(4). SECOND REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TOTHE BREAKAGE OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454899 ↗MalfunctionJan 13, 2026Use of Device Problem
THE SURGEON COULD NOT TIGHTEN THE SET SCREWS (USINGTHE FINAL TIGHTENER FROM MUST 2.0) ONTO THE TULIP OF TWO 6.0X35MM SCREWS, AS THE THREAD KEPT STRIPPING. NO DIFFERENT SETSCREW WAS USED BEFORE REMOVING THE PEDICLE SCREWS. THE PEDICLE SCREWS WERE EXPLANTED, AND 6.0X40MM PEDICLE SCREWS WERE INSERTED. THERE WAS A 30-MINUTE DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051153 ↗InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW (8MM X 40 MM) AT RIGHT SIDE OF L5, THE PATIENT'S PEDICLE BROKE. THE PATIENT'S BONES WERE OSTEOSCLEROTIC. BACK-UP USED (8MM X 50MM).
Patient problems: Bone Fracture(s)
MAUDE report 23725621 ↗InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN REVIEWING THE POST-OPERATIVE IMAGES ON THE SAME DAY OF THE SURGERY, BONE FRACTURE IN L2 AND L3 WAS DISCOVERED. COMPARED TO THE INTRAOPERATIVE TRAJECTORY ON NEXTAR SCREEN, THE SCREWS WERE INSERTED MORE LATERALLY, WHILE THE SCREWS APPEARED TO BE INSERTED WITH THE CORRECT TRAJECTORY DURING THE SURGERY. NO REVISION/ADDITIONAL SURGERY WAS PERFORMED OR PLANNED.
Patient problems: Bone Fracture(s)
MAUDE report 23669516 ↗MalfunctionNov 13, 2025No Apparent Adverse Event; No Apparent Adverse Event
DURING A POSTERIOR SPINAL SURGERY, THE FIRST STEP REDUCER FAILED TO PROPERLY ATTACH TO THE SCREW HEAD. INSPECTION REVEALED THAT A METAL PLATE WAS MISSING FROM THE DISTAL PART OF THE INSTRUMENT. INTRAOPERATIVE FLUOROSCOPY CONFIRMED THAT THE PIECE WAS NOT RETAINED INSIDE THE PATIENT; IT MAY HAVE ALREADY BEEN MISSING PRIOR TO SURGERY. ON THE RIGHT L5 SCREW, THE SECOND STEP REDUCER CAUSED THE SET SCREW TO REPEATEDLY CROSS-THREAD, DAMAGING THE SCREW HEAD THREADS. THIS REDUCER ALSO LOST THE SAME SMALL METAL COMPONENT. AS A RESULT, THE SURGEON REPLACED THE RIGHT L5 SCREW AND BENT THE ROD INTO GREATER LORDOSIS TO PLACE THE SET SCREW WITHOUT A PERSUADER, AS NO FUNCTIONING REDUCTION INSTRUMENT WAS AVAILABLE. SURGERY COMPLETED WITH 30/40 MIN DELAY (TOTAL TIME SURGERY 3 HOURS 10 MINUTES). NO PIECES LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543692 ↗MalfunctionNov 10, 2025Migration; Migration
PATIENT UNDERWENT SPINE FIXATION SURGERY (L3-L5) ON THE (B)(6) 2025. POST-OP FOLLOW-UP XRAY SHOWED DISLOCATION OF A SET SCREW FROM THE CONSTRUCT. ALTHOUGTH THE PROVIDED XRAY MAY SUGGEST THAT THE INVOLVED SCREW IS A Ø7X50 ONE, IT CANNOT BE CONFIRMED FROM WHICH SCREW THE SETSCREW DETACHED. PATIENT DOES NOT REPORT ANY PAIN AND CURRENTLY NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510654 ↗MalfunctionNov 10, 2025Migration; Migration
PATIENT UNDERWENT SPINE FIXATION SURGERY (L2-L5) ON THE (B)(6) 2024. POST-OP FOLLOW-UP XRAY SHOWED DISLOCATION OF A SET SCREW FROM THE CONSTRUCT. IT CANNOT BE CONFIRMED FROM WHICH SCREW THE SETSCREW DETACHED. PATIENT DOES NOT REPORT ANY PAIN AND CURRENTLY NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510652 ↗InjurySep 18, 2025Migration; Migration
FIXATION L4-L5. AFTER SURGERY, IT WAS RECOGNISED THAT A SET SCREW CAME OFF. THE PATIENT WAS IMMEDIATELY REOPERATED AND THE SETSCREW REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23081977 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 1 YEAR AND 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING BACK PAIN. SURGEON REMOVED TWO RIGHT-SIDE SCREWS AND ADDED BONE GRAFT. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22518024 ↗InjuryJun 25, 2025Break; Break
MODIFIED EVENT DESCRIPTION: REVISION SURGERY PERFORMED ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO S1 SCREWS BREAKAGE (BELOW THE HEAD). PATIENT WITH GOOD QUALITY BONE, HEAVY PATIENT (AROUND 90KG). NO TRAUMA REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22327510 ↗InjuryApr 3, 2025Fracture; Fracture
PRIMARY SURGERY WAS PERFORMED AT TH10-L3 DUE TO OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE. PEDICLE SCREW BREAKAGE OBSERVED AT LEFT SIDE OF L2 DURING REMOVAL SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21760521 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MONOSEGMENTAL LUMBAR SPINE SURGERY (L04, L05) WITH NEXTAR SYSTEM (VERSION 1.2.2). THE SURGEON USED THE DRILL, PLACED THE K-WIRES WITH THE NEXTAR DRILL GUIDE (3.2 MM, 40 MM DEPTH), FIRST ON THE RIGHT SIDE, THEN ON THE LEFT. AFTER THE PLACEMENT OF THE SCREWS, THE INTRA-OPERATIVE 3D SCAN SHOWS A LATERAL MISPLACEMENT OF BOTH RIGHT SCREWS. THE SURGEON REPLACED THE SCREWS ON THE RIGHT SIDE WITHOUT NAVIGATION, USING X-RAYS AND VISUALIZATION OF THE ANATOMICAL LANDMARKS. THE INSTRUMENTS WERE REMOVED AND THE SURGICAL WOUND WAS SUTURED. AFTER THE SURGERY, THE PATIENT WAS MOVED FROM THE OPERATION TABLE IN THE BED AND HAD A CIRCULATION COLLAPSE, THE AORTA AND VENA CAVA WERE REPAIRED IN AN EMERGENCY. THE BLEEDING WAS STOPPED SUCCESSFULLY AND THE PATIENT WAS FINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20639941 ↗InjuryAug 28, 2024Migration; Migration
PRIMARY SURGERY WAS PERFORMED AT TH9-S2AI. XLIF SURGERY WAS PERFORMED AT L1-L5, TLIF SURGERY WAS PERFORMED AT L5-S. REVISION SURGERY 6 DAYS AFTER THE PRIMARY SURGERY WAS PERFORMED DUE TO THE RODS COMING OUT FROM THE MUST S2AI PEDICLE SCREW HEAD. THE PEDICLE SCREWS AT BOTH SIDES OF SA1 WERE REPLACED WITH ANOTHER COMPETITOR'S SCREW. THE ROD AT THE LEFT SIDE WAS ALSO REPLACED BECAUSE THE LENGTH OF THE ROD WAS SHORT. IN THE X-RAYS THAT WERE TAKEN DURING THE PRIMARY SURGERY, THE ROD ON THE RIGHT SIDE SEEMED TO BE SHORT, BUT BY CHANGING THE ANGLE OF FLUOROSCOPY, IT WAS CONFIRMED THAT THE ROD WAS CORRECTLY PROTRUDED ABOUT 5 MM, AND THE SURGERY WAS FINISHED. THE PATIENT AND THE CONSTRUCT IS STABLE AFTER THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 20085911 ↗InjuryJan 19, 2024Migration; Migration
THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A SET SCREW HAD POPPED OUT. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON LOCKED DOWN THE ROD AND PUT IN A NEW SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. TORQUE LIMITER USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543707 ↗MalfunctionJan 19, 2024Fracture; Fracture
THE SURGEON BROKE MUST LT SCREW TAB AFTER THE FINAL FIXATION OF THE SET SCREW AT S1, BUT ONE TAB DID NOT BREAK CORRECTLY. THE REMAINING TAB WAS BROKEN WITH A PLIER AFTER ADDITIONAL CUTS. DELAY TIME WAS ABOUT 30 MIN AND TOTAL SURGERY TIME WAS ABOUT 3 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543624 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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