M.U.S.T. Pedicle Screw System 03.61.338Recalls & reported problems
Medacta International SA · Fenestrated polyax. cann. ped. scr. 7x45,dual-diam · 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
- 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 07630030862168), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury.
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
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MONOSEGMENTAL LUMBAR SPINE SURGERY (L04, L05) WITH NEXTAR SYSTEM (VERSION 1.2.2). THE SURGEON USED THE DRILL, PLACED THE K-WIRES WITH THE NEXTAR DRILL GUIDE (3.2 MM, 40 MM DEPTH), FIRST ON THE RIGHT SIDE, THEN ON THE LEFT. AFTER THE PLACEMENT OF THE SCREWS, THE INTRA-OPERATIVE 3D SCAN SHOWS A LATERAL MISPLACEMENT OF BOTH RIGHT SCREWS. THE SURGEON REPLACED THE SCREWS ON THE RIGHT SIDE WITHOUT NAVIGATION, USING X-RAYS AND VISUALIZATION OF THE ANATOMICAL LANDMARKS. THE INSTRUMENTS WERE REMOVED AND THE SURGICAL WOUND WAS SUTURED. AFTER THE SURGERY, THE PATIENT WAS MOVED FROM THE OPERATION TABLE IN THE BED AND HAD A CIRCULATION COLLAPSE, THE AORTA AND VENA CAVA WERE REPAIRED IN AN EMERGENCY. THE BLEEDING WAS STOPPED SUCCESSFULLY AND THE PATIENT WAS FINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20639941 ↗
Other Bone Cement, Posterior Screw Augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723535Medos International Sàrl · bone cement, posterior screw augmentation4 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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