M.U.S.T. Pedicle Screw System 03.57.012Recalls & reported problems
Medacta International SA · MUST LT 15mm SHORT - Pedicle Screw Ø5x30 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971278295), received between Jan 19, 2023 and Jan 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2023Break; Break
THE PEDICLE SCREW CAME OFF FROM THE VERTEBRAL BODY WHEN THE ROD WAS INSERTED INTO THE SCREW TABS. NO NEW SCREWS WERE INSERTED INTO THE VERTEBRAL BODY AT THIS LEVEL, AND FIXATION WAS PERFORMED ONLY WITH SCREWS AND RODS PLACED AT ANOTHER LEVEL. AFTER INSERTING THE ROD, THE FINAL FASTENING WAS PERFORMED WITH THE SET SCREW. WHEN AN ATTEMPT WAS MADE TO REMOVE THE ROD FROM THE INSERTER, THE LOCKING MECHANISM (HANDLE FOR GRIPPING THE ROD) OF THE INSTRUMENT WAS STUCK AND COULD NOT BE REMOVED. IT WAS FORCEFULLY UNLOCKED WITH PLIERS. ANOTHER ROD WAS THEN USED AND FASTENED WITH THE SET SCREW, WHEN TRYING TO REMOVE THE ROD FROM THE INSERTER THE ROD COULD NOT BE REMOVED AND THE GRIPPING MECHANISM OF THE INSTRUMENT BROKE. THE PART BROKEN REMAINED IN THE PATIENT BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY IN 3.5 HOURS WITH 30 MINUTES OF DELAY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16204617 ↗
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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