M.U.S.T. Polyaxial Pedicle Screw 03.50.093Recalls & reported problems
Medacta International SA · Pedicle screw 10x45mm + Nut (1x) - Sterile · Class 2 · Implant
All models of M.U.S.T. Polyaxial Pedicle Screw (25)
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 07630030834721), received between May 20, 2025 and May 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Use of Device Problem; Use of Device Problem
SPINAL FIXATION WAS PERFORMED AT L3-SAI. AFTER INSERTION OF THE ROD, FINAL TIGHTENING WAS PERFORMED, BUT THE RIGHT SIDE OF L5 COULD NOT BE TORQUED PROPERLY. AN OMINOUS NOISE LED THE SURGEON TO CONCLUDE THAT CROSS-THREADING HAD OCCURRED AND REPLACED THE SET SCREW, THEN REINSERTED THE SET SCREW, BUT CROSS-THREADED OCCURED AGAIN. THE SURGEON CONCLUDED THAT THE PEDICLE SCREW HEAD THREADS WERE FAULTY AND REPLACED IT WITH A NEW SCREW (LOT:2229775), COMPLETING THE SURGERY. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR AND 30 MINUTES. THE DELAY WAS DUE TO MULTIPLE ATTEMPTS TO INSERT THE SET SCREW ,AND THE SURGEON ONCE REMOVED THE ROD AND THEN REPLACE THE NEW PEDICLE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051616 ↗
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- 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
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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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