NA 407.646Recalls & reported problems
Synthes GmbH · 4.0MM TI CANNULATED SCREW SHORT THREAD/46MM · Class 2 · Implant
Data updated Oct 16, 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 10886982208460), received between Aug 4, 2021 and Aug 4, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2021Migration; Migration
IT WAS REPORTED THAT PARTS WERE IMPLANTED IN 2017. LAST YEAR THE SCREWS STARTED BACKING OUT, AND THE PLATE AND SCREWS WERE REMOVED IN (B)(6) 2020. A NEW PLATE. WAS NOT IMPLANTED AT THAT TIME DUE TO HOSPITAL RESTRICTIONS ON SURGERIES DUE TO COVID. A NEW PLATE WAS IMPLANTED IN (B)(6) 2021. PATIENT STATUS IS UNKNOWN. NO SURGICAL DELAY. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) 4.0 TI CANNULATED SCREW SHORT THREAD/46. THIS REPORT IS 2 OF 6 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12277526 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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