M.U.S.T. Monoaxial Pedicle Screw 03.50.233Recalls & reported problems
Medacta International SA · Monoaxial screw 5x40mm + Nut (1x) - Sterile · Class 2 · Implant
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 07630030834981), received between Sep 6, 2019 and Sep 10, 2019 — classified as 1 injury, 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
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2019Break; Break
THE PATIENT CAME IN, 5 DAYS AFTER PRIMARY SURGERY, COMPLAINING OF BILATERAL KNEE NUMBNESS. THE SURGEON REVISED ONE BROKEN PEDICLE SCREW.. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Numbness
MAUDE report 8979017 ↗MalfunctionSep 6, 2019Material Deformation; Material Deformation
DURING THE PRIMARY SPINE SURGERY, AND WHILE THE SURGEON WAS REDUCING THE ROD, THE INSIDE OF THE MONO SCREW STRIPPED. THE SURGEON REMOVED THE SET CAPS AND ROD ALONG WITH THE STRIPPED SCREW FROM THE PATIENT. THE SURGEON IMPLANTED A NEW SCREW AND ROD AND REPLACED ALL THE SET CAPS IN THE CONSTRUCT AND THEN PLACED THE ROD ON THE OTHER SIDE AND COMPLETED THE CASE. THE SURGERY WAS DELAYED BY 2 HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8969431 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page