M.U.S.T. Polyaxial Pedicle Screw 03.50.018Recalls & reported problems
Medacta International SA · Pedicle screw 6x45mm + Nut (1x) - Sterile · Class 2 · Implant
All models of M.U.S.T. Polyaxial Pedicle Screw (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030834219), received between Feb 1, 2018 and Jul 5, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K121115); they may or may not involve this specific model.
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
- Break1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2019Material Twisted/Bent; Material Twisted/Bent
PLIF SURGERY WAS PERFORMED AT L4-L5. THE SURGEON WAS NOT ABLE TO INSERT THE SET SCREWS INTO THE PEDICLE SCREW HEAD AT THE LEFT SIDE OF L4, SO THE SURGEON DISENGAGED THE SET SCREW, AND DISCOVERED CROSS-THREADING ON 2 SET SCREWS. EVEN THOUGH THE SURGEON REPLACED THE NEW SET SCREW, CROSS-THREADING REOCCURRED, SO THE SURGEON HAD TO REPLACE THE NEW PEDICLE SCREW. THE SAME EVENT ALSO OCCURRED AT THE RIGHT SIDE OF L4. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8764349 ↗InjuryFeb 1, 2018Break; Break
REVISION SURGERY PERFORMED TWO YEARS AFTER PRIMARY DUE TO PAIN CAUSED PROBABLY BY A PEDICLE SCREW BREAKAGE.
Patient problems: Pain
MAUDE report 7233960 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121115. One submission often covers many models, so check the product and lot details in each record.
- Z-1023-2017 · Dec 7, 2016 · TerminatedMedacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to
Other Orthosis, Spinal Pedicle Fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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