M.U.S.T. Polyaxial Pedicle Screw 03.52.314Recalls & reported problems
Medacta International SA · Enh. Cann. Pedicle Screw 5x40mm + 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030857461), received between Apr 14, 2023 and Jan 10, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Malposition of Device” (2 reports).
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
- Malposition of Device2
- Failure to Osseointegrate1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2024Malposition of Device; Malposition of Device
THE SEVERELY OVERGROWN FACET DISPLACED THE GUIDE SLIGHTLY AND ENDED UP WITH A PILOT HOLE THAT WAS TOO MEDIAL. IT WAS IMMEDIATELY RECOGNIZED AND ABLE TO BE RE-DIRECTED WITH END CONSTRUCT BEING PERFECT. UNFORTUNATELY THE PATIENT DEVELOPED A DELAYED RADICULITIS, WHICH REQUIRED A RETURN TO THE OR AND HAD TO REDUCE A HERNIATED NERVE ROOTLET THROUGH THE SMALL DUROTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18481932 ↗InjuryJul 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
2 PEDICLE CANNULATED SCREWS WERE FOUND LOOSE DURING REVISION SURGERY FOR PATIENT'S BACK PAIN (10 MONTHS POST PRIMARY). LEVEL L4-L5.
Patient problems: Pain
MAUDE report 17389620 ↗InjuryApr 14, 2023Malposition of Device; Migration; Malposition of Device; Migration
ABOUT 12 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE RIGHT L2 AND L3 SCREWS WERE OUTSIDE THE VERTEBRAL BODY. THE SCREWS WERE PROBABLY MISPLACED DURING THE PRIMARY SURGERY; ALTHOUGH THE POSITION WAS CHECKED DURING SURGERY WITH FLUOROSCOPY. THE SURGEON REVISED THE 2 MISPLACED SCREWS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT WITH SCOLIOSIS. NO ISSUE WITH THE MYSPINE GUIDES OCCURRED DURING THE PRIMARY SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16741313 ↗
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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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