M.U.S.T. Monoaxial Pedicle Screw 03.50.244Recalls & reported problems
Medacta International SA · Monoaxial screw 6x45mm + Nut (1x) - Sterile · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030835087), received between Jul 30, 2019 and Jul 30, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2019Material Fragmentation; Material Fragmentation
DURING THE REVISION SPINE SURGERY, AND WHILE THE SURGEON WAS TIGHTENING THE SET SCREW AFTER ADJUSTING THE ROD, THE INTERNAL THREADS ON THE TULIP BROKE. FRAGMENTS FELL INTO THE PATIENT AND WERE RETRIEVED AND THE SURGEON COMPLETED THE CASE BY IMPLANTING A POLY-AXIAL REDUCTION SCREW. THERE WAS A 15-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8840209 ↗
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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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