M.U.S.T. Polyaxial Pedicle Screw 03.50.061Recalls & reported problems
Medacta International SA · Pedicle screw 8x75mm + 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 07630030834486), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Solder Joint 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.
Most reported problems
Device problems
- Solder Joint Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2018Solder Joint Fracture; Solder Joint Fracture
PLIF SURGERY PERFORMED AT L3-S1 AND SCREW FIXATION AT L2-S2AI. THE SURGEON TRIED TO TIGHTEN THE SET SCREW WITH THE TWO-STEP REDUCER ENHANCED. AFTER THAT ONE BROKEN PIN OF THE TWO-STEP REDUCER WAS DISCOVERED IN THE PATIENT BODY. SINCE THE SET SCREW DID NOT INSERT WITH THE BACK UP TWO-STEP REDUCER, THE SURGEON REMOVED ALL SET SCREWS AND BENT THE ROD AGAIN. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. AFTER THE SURGERY IT WAS FOUND THAT 3 PINS OF THE TWO-STEP REDUCER WAS MISSING. 1 OUT OF 3 PINS WAS DISCOVERED IN THE PATIENT BODY. THE OTHER 2 PINS WERE NOT FOUND IN THE PATIENT BODY THROUGH THE X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 7955807 ↗
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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
- 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.
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