M.U.S.T. Midline Cortical (MC) Screw System 03.58.263Recalls & reported problems
Medacta International SA · MUST MC Screw Ø7x35 cannulated · Class 2 · Implant
All models of M.U.S.T. Midline Cortical (MC) Screw System (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971293755), received between Sep 6, 2024 and Sep 9, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bone Fracture(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Spinal fixation was performed at L4-L5. The L5 pedicle fractured after the rod was inserted. The trajectory was changed from CBT to PS, and the same screw was reinserted. As the trajectory was altered, the required rod length changed, and a new rod (50 mm) was used. No critical delay.The quality of the patient`s bone was unknown.
Patient problems: Bone Fracture(s)
MAUDE report 50692269 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SPINAL FIXATION WAS PERFORMED AT L4-S WITH MYSPINE MC GUIDE. AFTER THE TAPPING 6MM(UNDER) AT RIGHT SIDE OF S1, DURING THE INSERTION OF THE PEDICLE SCREW, THE PATIENT BONE BROKE. THE SURGEON CHANGED THE TRAJECTORY AND REPLACED THE SCREW WITH A NEW ONE (6 X 40MM). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE IS REPORTED TO BE SCLEROTIC.
Patient problems: Bone Fracture(s)
MAUDE report 20154521 ↗
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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