M.U.S.T. Pedicle Screw System 03.57.035Recalls & reported problems
Medacta International SA · MUST LT 15mm SHORT - Pedicle Screw Ø7x45 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971278462), received between Nov 18, 2022 and Apr 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
- 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.
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 18, 2022Osseointegration Problem; Osseointegration Problem
AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, A REVISION SURGERY WAS PERFORMED BECAUSE 4 OF THE 6 REPORTED SCREWS BACKED OUT. MOREOVER, DURING THE REVISION A SCREW WAS REPLACED WITH NEW ONE BUT IT WAS LOOSENED DURING ROD FIXATION. THE SCREW WAS REPLACED AGAIN AND A COMPLAINT WAS OPENED. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY WITHOUT CRITICAL DELAY.
Patient problems: Inadequate Osseointegration
MAUDE report 15824408 ↗
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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