M.U.S.T. Polyaxial Pedicle ScrewRecalls & reported problems across all models
Medacta International SA · 25 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 25 models of M.U.S.T. Polyaxial Pedicle Screw by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2017 and Sep 30, 2026 — classified as 50 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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. Polyaxial Pedicle Screw problems
Device problems
- Fracture9
- Appropriate Device Problem Term/Code Not Available7
- Break7
- Loosening of Implant Not Related to Bone-Ingrowth6
- Adverse Event Without Identified Device or Use Problem5
- Loose or Intermittent Connection4
- Device Appears to Trigger Rejection3
- Failure to Osseointegrate3
Patient problems
- No Known Impact Or Consequence To Patient10
- Pain8
- Bone Fracture(s)6
- Implant Pain6
- Inadequate Osseointegration5
- Unspecified Infection5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Foreign Body In Patient3
M.U.S.T. Polyaxial Pedicle Screw models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M.U.S.T. Polyaxial Pedicle Screw 03.52.323Appliance, Fixation, Spinal Intervertebral Body10 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.322Orthosis, Spinal Pedicle Fixation8 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.030Appliance, Fixation, Spinal Interlaminal4 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.031Orthosis, Spinal Pedicle Fixation4 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.324Orthosis, Spinal Pedicle Fixation4 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.032Appliance, Fixation, Spinal Interlaminal3 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.054Appliance, Fixation, Spinal Interlaminal3 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.314Appliance, Fixation, Spinal Intervertebral Body3 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.339Appliance, Fixation, Spinal Intervertebral Body3 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.018Orthosis, Spinal Pedicle Fixation2 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.325Appliance, Fixation, Spinal Intervertebral Body2 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.52.336Orthosis, Spinal Pedicle Fixation2 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.011Appliance, Fixation, Spinal Interlaminal1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.012Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.016Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.017Appliance, Fixation, Spinal Interlaminal1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.019Appliance, Fixation, Spinal Interlaminal1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.020Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.056Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.061Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.076Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.093Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.52.321Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.52.337Appliance, Fixation, Spinal Intervertebral Body1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.52.338Orthosis, Spinal Pedicle Fixation1 report
Recent M.U.S.T. Polyaxial Pedicle Screw adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMay 27, 2026Fracture
THE PATIENT UNDERWENT PRIMARY SURGERY WITH IMPLANTATION OF A MUST SOLID SCREW 6 X 55 MM AT RIGHT L3. APPROXIMATELY TEN DAYS AFTER SURGERY, THE PATIENT STARTED EXPERIENCING LEG PAIN, WITH NO REPORTED TRAUMATIC EVENT. THE PATIENT`S BONE QUALITY WAS DESCRIBED AS GOOD. DUE TO PERSISTENT PAIN, REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE MONTHS AFTER THE PRIMARY PROCEDURE. DURING THE REVISION, THE RIGHT L3 MUST SOLID SCREW WAS FOUND FRACTURED, AND A PEDICLE BONE FRACTURE WAS ALSO IDENTIFIED AT LEFT L3. THE CRANIAL/PROXIMAL PORTION OF THE FRACTURED SCREW WAS REMOVED, WHILE THE CAUDAL/DISTAL PORTION WAS LEFT EMBEDDED IN THE BONE. THE SCREW FRACTURE AND THE PEDICLE BONE FRACTURE WERE REPORTEDLY NOT VISIBLE DURING THE FOLLOW-UP VISIT/IMAGING PRIOR TO REVISION.
Patient problems: Bone Fracture(s); Implant Pain
MAUDE report 25297687 ↗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 ↗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 ↗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 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 2 MONTHS AND A HALF FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THAT A LOOSE SCREW HAD CAUSED THE CAGE TO BECOME SUBSIDED. THE SURGEON REVISED THE SCREW FROM A 6X50MM TO A 7X50MM.LEVELS WERE L4-5.THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 23461659 ↗MalfunctionMay 20, 2025Use of Device Problem; Use of Device Problem
SPINAL FIXATION WAS PERFORMED AT L3-SAI. AFTER INSERTION OF THE ROD, FINAL TIGHTENING WAS PERFORMED, BUT THE RIGHT SIDE OF L5 COULD NOT BE TORQUED PROPERLY. AN OMINOUS NOISE LED THE SURGEON TO CONCLUDE THAT CROSS-THREADING HAD OCCURRED AND REPLACED THE SET SCREW, THEN REINSERTED THE SET SCREW, BUT CROSS-THREADED OCCURED AGAIN. THE SURGEON CONCLUDED THAT THE PEDICLE SCREW HEAD THREADS WERE FAULTY AND REPLACED IT WITH A NEW SCREW (LOT:2229775), COMPLETING THE SURGERY. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR AND 30 MINUTES. THE DELAY WAS DUE TO MULTIPLE ATTEMPTS TO INSERT THE SET SCREW ,AND THE SURGEON ONCE REMOVED THE ROD AND THEN REPLACE THE NEW PEDICLE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051616 ↗InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
REVISION SURGERY AT 1 YEAR 8 MONTHS DUE TO A 6MM LOOSE SCREW. THE SURGEON IMPLANTED A 7MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21595453 ↗InjuryOct 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection; Unspecified Infection
MAUDE report 20544242 ↗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 ↗InjuryMay 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT CAME IN REPORTING PAIN DUE TO LACK OF FUSION ON LEFT L5/S1. IT IS UNKNOWN WHY THIS OCCURRED. AT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON REMOVED ALL IMPLANTS AND REIMPLANTED NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 19307529 ↗InjuryJan 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 3 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON REVISED THE M.U.S.T SCREWS IN THE ORIGINAL CONSTRUCT AT L2 - L4, WITH M.U.S.T. MC SCREWS AND EXTENDED THE CONSTRUCT TO NOW INCLUDE L4 - L5. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 18524978 ↗InjuryJan 10, 2024Malposition of Device; Malposition of Device
THE SEVERELY OVERGROWN FACET DISPLACED THE GUIDE SLIGHTLY AND ENDED UP WITH A PILOT HOLE THAT WAS TOO MEDIAL. IT WAS IMMEDIATELY RECOGNIZED AND ABLE TO BE RE-DIRECTED WITH END CONSTRUCT BEING PERFECT. UNFORTUNATELY THE PATIENT DEVELOPED A DELAYED RADICULITIS, WHICH REQUIRED A RETURN TO THE OR AND HAD TO REDUCE A HERNIATED NERVE ROOTLET THROUGH THE SMALL DUROTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18481932 ↗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 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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