Mica Screw System 57S13036Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420183385), received between Oct 28, 2022 and Oct 19, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE HEAD OF THE SCREW SNAPPED OFF DURING INSERTION INTO THE TOE. THE SURGEON WAS ABLE TO REMOVE THE HEAD OF THE SCREW BUT THE BODY REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17969624 ↗MalfunctionOct 28, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE SCREW BROKE DURING INSERTION IN THE PATIENTS FOOT. THE SHAFT WAS NOT ABLE TO BE REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15691752 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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