M.U.S.T. MINI Polyaxial Screw 03.75.007Recalls & reported problems
Medacta International SA · Polyaxial Screw 3.5 x 24 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 07630030863219), received between Jul 14, 2020 and Jul 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
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 14, 2020Loose or Intermittent Connection
DURING A POST-OP VISIT, IT WAS OBSERVED THAT ONE SET SCREW WAS DISENGAGED FROM THE MUST MINI SCREW AND TWO OTHER SET SCREWS WERE LOOSE. THE SURGEON REVISED THE POLY-AXIAL SCREWS AT C7 AND T2 WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE SET SCREWS IN ALL REMAINING MEDACTA POLY-AXIAL SCREWS WITH MEDACTA SET SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. 2 SET SCREWS LOOSE AND 1 UNSCREWED. THE TWO PEDICLE SCREWS WERE REVISED DUE TO THE FACT THAT THE SURGEON WANTED A MORE ROBUST CONSTRUCT AND HE IMPLANTED 2 PEDICLE SCREWS AND A 3.5MM - 6.0MM TRANSITION ROD. THE SURGEON REMOVED THE SET SCREWS BECAUSE HE HAD TO REMOVE THE ROD SO IT WAS NECESSARY TO REMOVE SCREWS. THE 3NM SCREWDRIVER HAS BEEN USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10269860 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page