M.U.S.T. MINI Polyaxial Screw 03.75.005Recalls & reported problems
Medacta International SA · Polyaxial Screw 3.5 x 20 Full thread + nut · Class 2 · Implant
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 07630030863196), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Issue” (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
- Device Issue1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2018Device Issue; Device Issue
THE C2-C7 POSTERIOR CERVICAL FUSION. LATERAL MASS AND PEDICLE SCREWS HAD BEEN PLACED BILATERALLY. ROD PLACED BILATERALLY. PHYSICIAN HAD DIFFICULTY INSERTING SET SCREWS INTO TULIP HEADS OF SCREWS. SURGEON ATTEMPTED TO USE ROD REDUCTION DEVICE, ROD PUSHER , AND COUNTER-TORQUE FOUR ARMS TO ATTEMPT TO SEAT RODS AND ENGAGE SET CAPS IN TULIP HEAD. SIX MUST-C SETSCREWS HAD TO BE WASTED IN EFFORTS TO SEAT SCREWS AND FINALLY TIGHTEN. PHYSICIAN STATED THAT TULIP HEADS SPLAYED AND SET SCREWS WERE CROSS-THREADED. THIS ADDED AN ADDITIONAL HOUR TO THE PATIENT'S PROCEDURE AND THE PHYSICIAN STATED HE WAS UNABLE TO ACHIEVE THE DESIRED DEGREE OF CERVICAL LORDOSIS DUE TO THE INABILITY TO REDUCE OFF OF THE TULIP HEAD OF THE SCREWS.
Patient problems: Failure of Implant
MAUDE report 7237222 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 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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