M.U.S.T. MINI Polyaxial Screw 03.75.002Recalls & reported problems
Medacta International SA · Polyaxial Screw 3.5 x 14 Full thread + nut · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030863165), received between Nov 25, 2020 and May 15, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Appropriate Device Problem Term/Code Not Available2
- Difficult to Insert1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Bone Fracture(s)2
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
C2-C7 FIXATION SURGERY. PATIENT'S PEDICLE BONE CRACKED AT C6 RIGHT SIDE WHILE INSERTING THE 3.5X14 PEDICLE SCREW (2.7 DIAMETER TAPPING PERFORMED). STRONG BONE. C6 LEVEL WAS SKIPPED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 22025605 ↗InjuryOct 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING THE SPINE SURGERY, A BONE FRACTURE WAS OBSERVED WHILE INSERTING THE MUST MINI POLYAXIAL SCREW 3.5 X 14. ANOTHER SCREW WAS USED, ALSO CHANGING THE SCREW TRAJECTORY. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY. 10 MINUTES DELAY. TOTAL SURGERY TIME 4 HOURS. THE BONE SEEMD TO BE HARD.
Patient problems: Bone Fracture(s)
MAUDE report 20469756 ↗MalfunctionMay 24, 2022Difficult to Insert; Difficult to Insert
DURING THE PRIMARY SPINE SURGERY, DURING FINAL IMPLANTATION, WHEN THE SURGEON WAS TORQUING OUT THE RODS, 3 OF THE SET SCREWS WERE NOT ABLE TO BE TORQUED DOWN. THE SURGEON HAD TO REMOVE THE SCREWS AND IMPLANT NEW SCREWS. THERE WAS A 30-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14485015 ↗InjuryNov 25, 2020Inadequacy of Device Shape and/or Size
SPINAL FIXATION WAS PERFORMED AT C2-T2. OPEN SURGERY. THE BONE QUALITY SEEMED TO BE LOW. WHEN THE SURGEON ENGAGED THE CERVICAL SCREW WITH THE ROD AT LEFT SIDE OF C2, THE CERVICAL SCREW WAS PULLED OUT FROM THE PATIENT BODY BECAUSE THE CERVICAL SCREW WAS NOT ABLE TO WITHSTAND THE LOAD. THE SURGEON DECIDED TO DO NOT IMPLANT THE SCREW IN C2 LEFT. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. TOTAL SURGERY TIME WAS 280MINS.
Patient problems: Failure of Implant
MAUDE report 10905039 ↗
Other Orthosis, Cervical Pedicle Screw Spinal Fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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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