M.U.S.T. Polyaxial Pedicle Screw 03.52.325Recalls & reported problems
Medacta International SA · Enh. Cann. Pedicle Screw 6x50mm + 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 07630030857607), received between Oct 31, 2018 and Nov 4, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
Patient problems
- Aseptic loosening1
- Implant Pain1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 2 MONTHS AND A HALF FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THAT A LOOSE SCREW HAD CAUSED THE CAGE TO BECOME SUBSIDED. THE SURGEON REVISED THE SCREW FROM A 6X50MM TO A 7X50MM.LEVELS WERE L4-5.THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 23461659 ↗InjuryOct 31, 2018Malposition of Device
PATIENT CAME IN COMPLAINING OF PAIN 2 MONTHS AFTER PRIMARY. THE SURGEON THOUGHT THE SCREWS MAY HAVE BEEN FRACTURED. UPON OPENING THE PATIENT, THE SURGEON DETERMINED THAT THE SCREWS WERE NOT FRACTURED. THE SURGEON WAS DISPLEASED WITH SCREWS PLACEMENT. THE SURGEON REVISED 2 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8023978 ↗
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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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