M.U.S.T. Polyaxial Pedicle Screw 03.52.336Recalls & reported problems
Medacta International SA · Enh. Cann. Pedicle Screw 7x35mm + 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030857744), received between Mar 10, 2021 and Oct 27, 2023 — classified as 2 injuries.
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 Problem2
Patient problems
- Bacterial Infection1
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING FINAL TIGHTENING WITH THE ROD AT S1 RIGHT SIDE (MYSPINE CASE), THE PEDICLE SCREW MOBILIZED AFTER THE FRACTURE OF THE PATIENT BONE. ANOTHER PEDICLE SCREW HAS BEEN IMPLANTED WITH A DIFFERENT TRAJECTORY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN REPORTED THAT THE PATIENT BONE WAS WEAK.
Patient problems: Bone Fracture(s)
MAUDE report 18021798 ↗InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 3 CANN. PEDICLE SCREWS 6X45MM + NUT (1X) STERILE, 1 CANN. PEDICLE SCREW 7X35MM + NUT (1X) STERILE, 1 CANN. PEDICLE SCREW 7X40MM + NUT (1X) STERILE, 1 CANN. PEDICLE SCREW 6X50MM + NUT (1X) STERILE, AND 2 BENT RODS TI R200 5.5X70MM - STERILE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bacterial Infection
MAUDE report 11453396 ↗
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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