NA 207.618Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED SCREW SHORT THREAD/18MM · 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 10886982148094), received between May 4, 2018 and May 4, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE SURGEON INQUIRED AS TO THE METAL COMPOSITION OF THE 4.0MM CANNULATED SCREW. THE DEVICE WAS IMPLANTED ON UNKNOWN DATE. SURGEON CONFIRMED NO ALLERGIC REACTION TO THE DEVICE, BUT BELIEVES MECHANICAL IRRITATION FROM NORMAL MOTION AT THE LISFRANC¿S JOINT DEVELOPED. IT IS NOT KNOWN IF DEVICE WAS EXPLANTED. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD 18MM THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Irritation
MAUDE report 7487100 ↗
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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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