M.U.S.T. MINI Polyaxial Screw 03.75.201Recalls & reported problems
Medacta International SA · Cannulated Polyaxial Screw 4.0 x 12 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030863790), received between Aug 11, 2025 and Aug 11, 2025 — 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
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING SURGERY FOR METASTATIC SPINAL TUMOR, FIXATION WAS PERFORMED FROM C3 TO C6 USING LATERAL SCREWS. C4-5 WAS SKIPPED DUE TO THE PRESENCE OF A TUMOR. A BONY TUNNEL WAS CREATED USING THE MYSPINE GUIDE, AND AFTER DECOMPRESSION, SCREWS WERE INSERTED. AT THE STAGE OF ROD FIXATION, A FRACTURE OCCURRED AT THE BASE OF THE SCREW AT C6 (L), PROMPTING AN EXTENSION OF THE FIXATION TO BILATERAL C7. ALTHOUGH AN ATTEMPT WAS MADE TO INSERT A PEDICLE SCREW VIA THE LATERAL MASS AT C7 (L), IT INTERFERED WITH THE SPINAL CANAL AND WAS SUBSEQUENTLY REMOVED. A PEDICLE SCREW WAS THEN INSERTED FREEHAND ALONG THE PS TRAJECTORY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Bone Fracture(s)
MAUDE report 22769926 ↗
Other Appliance, Fixation, Spinal Interlaminal devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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