NA 207.758Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED SCREW-LONG THREAD 58MM · 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 10886982148599), received between Apr 6, 2021 and Apr 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2021Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. IT WAS NOTICED THAT THE CANNULATED SCREW-LONG THREAD 58MM, AND THE SCREW BROKE AT THE THREAD/ SHAFT JUNCTION. TRIED TO REMOVE USING A BROKEN SCREW REMOVAL SET. THE SCREW WAS UNABLE TO BE REMOVED, LEFT THE THREADED PORTION OF THE SCREW IN THE PATIENT. FRAGMENTS WERE GENERATED. THERE WERE 30 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED WITH 30-MINUTES DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 4.0MM CANNULATED SCREW-LONG THREAD 58MM. THIS REPORT IS 1 OF 1 (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11624482 ↗
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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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