M.U.S.T. Pedicle Screw System 03.57.024Recalls & reported problems
Medacta International SA · MUST LT 15mm SHORT - Pedicle Screw Ø6x40 Cann · Class 2 · Implant
All models of M.U.S.T. Pedicle Screw System (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971278387), received between Sep 8, 2021 and Nov 3, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Failure to Advance1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2021Failure to Advance
THE SURGEON COULDN`T INSERT THE PEDICLE SCREW INTO THE PATIENT`S BONE DESPITE HE PERFORMED TAPPING. THE SAME PROBLEM OCCURRED WITH TWO OTHER SCREWS OF THE SAME SIZE. FINALLY, HE USED 7MM SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 1 HOUR OF DELAY AND A TOTAL SURGERY TIME OF 3.5H. THE SURGERY WAS L4/L5 FUSION. THIS EVENT OCCURRED DURING INSERTING L5 SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12743398 ↗InjurySep 8, 2021Detachment of Device or Device Component
PRIMARY SURGERY WAS PERFORMED ON (B)(6). THERE WAS NO ABNORMALITY IN THE EXAMINATION ONE WEEK AFTER THE PRIMARY SURGERY. THE PATIENT HAD A CT SCAN ABOUT ONE MONTH AFTER THE PRIMARY SURGERY AND THE SURGEON NOTICED RODS DISENGAGEMENT. THE SURGEON REVISED ROD AND L4 SCREW ON THE (B)(6) 2021. AT THE TIME OF PRIMARY SURGERY, THE SURGEON MEASURED THE ROD LENGTH WITH ROD MEASURING DEVICE REF (B)(4), THE ROD LENGTH WAS ENOUGH. THE FINAL TIGHTENING WAS DONE CORRECTLY DURING PRIMARY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12438319 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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