M.U.S.T. Polyaxial Pedicle Screw 03.52.337Recalls & reported problems
Medacta International SA · Enh. Cann. Pedicle Screw 7x40mm + 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
- 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 07630030857751), received between Oct 10, 2019 and Oct 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
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.
InjuryOct 10, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PPS SURGERY PERFORMED AT L4/5. THE PATIENT BONE QUALITY WAS POOR. THE ENH. POLY-AXIAL PEDICLE SCREW CANNULATED 7X40MM WAS INSERTED AT THE LEFT OF L4, BUT IT LOOSENED. ONE POSSIBLE REASON WAS THE PEDICLE SCREW THREAD WAS NOT FULLY DESIGNED, SO THE THREAD COULD NOT BE FIXED AT THE CORTICAL BONE COMPLETELY AND IT WAS NOT ABLE TO OBTAIN THE FIXING FORCE. THE REVISION SURGERY PERFORMED IMMEDIATELY BY OPEN SURGERY. PEDICLE SCREW WAS REPLACED WITH THE BACKUP SOLID SCREW. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. TOTAL SURGERY TIME WAS 180MIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9174355 ↗
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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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