M.U.S.T. Pedicle Screw System 03.57.044Recalls & reported problems
Medacta International SA · MUST LT 15mm SHORT - Pedicle Screw Ø8x40 Cann · Class 2 · Implant
All models of M.U.S.T. Pedicle Screw System (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971278523), received between Mar 29, 2023 and Dec 5, 2025 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Bone Fracture(s)1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW (8MM X 40 MM) AT RIGHT SIDE OF L5, THE PATIENT'S PEDICLE BROKE. THE PATIENT'S BONES WERE OSTEOSCLEROTIC. BACK-UP USED (8MM X 50MM).
Patient problems: Bone Fracture(s)
MAUDE report 23725621 ↗DeathMar 29, 2023Migration; Migration
A MEDTRONIC'S SOLERA SCREW WAS PLACED ON L4/L5 AT THE PRIMARY SURGERY (WE DO NOT KNOW WHEN AND WHERE WAS PERFORMED). L5 RT SCREW SEEMS LIKE ALREADY LOOSENED OR MISPLACED. AFTER THE REMOVING OF THE EXISTING SCREW, THE MUST LT 7MM SCREW WAS PLACED BUT IT WAS NOT SECURED OR TIGHTENED ENOUGH SO THE SURGEON DECIDED TO REPLACE WITH MUST LT 8MM SCREW. WHEN THE 7MM LT SCREW WAS REMOVED, BLOOD BLEEDING WAS OBSERVED SO THE SURGEON PRESSED IT OVER AND STOPPED IT. THEN MUST LT 8MM SCREW WAS PLACED. ONCE IT WAS PLACED AND TRIED TO PUT THE SETSCREW, THEN THE LT SCREW WAS BACKED OUT. THE SURGEON DECIDED TO REMOVE THE 8MM LT SCREW AND LEFT WITHOUT ANY SCREW ON L5 RT, THEN STARTED TO CLOSE THE WOUND, BUT REALIZED THE BLEEDING WAS NOT STOPPED YET. THE PATIENT WAS TAKEN TO AN EMERGENCY HOSPITAL AND DIED THE DAY AFTER.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16633976 ↗
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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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