M.U.S.T. Combined Set Screw 03.50.206Recalls & reported problems
Medacta International SA · MUST Combined Setscrew H4-T27 - (6x) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040717069), received between Mar 13, 2019 and Jul 12, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2019Material Integrity Problem; Material Integrity Problem
THE SET SCREW BROKE DURING INSERTION INTO THE TULIP. IT HAS BEEN REPLACED, AND THE TWO FRAGMENTS WERE REMOVED FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8783962 ↗MalfunctionMar 13, 2019Material Deformation; Material Deformation
AFTER IMPLANTING THE PEDICLE SCREWS, IT WAS DIFFICULT TO FIX THE ROD ON THE LEFT SIDE. WHEN THE CAGE ON L5-S1 WAS INSERTED, THE SURGEON TRIED TO PERFORM SOME COMPRESSION FORCE ON THE SEGMENT, AT THIS TIME, WHEN THEY TRIED TO FIX THE COMBINED SET SCREW, 2 THREADS OF 2 SET SCREWS HAVE BEEN BROKEN. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY USING A NEW ROD, DEFORMED A LITTLE BIT MORE AND NEW SET SCREWS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8416467 ↗
Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices
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- 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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