NA 02.214.104Recalls & reported problems
Synthes GmbH · 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 4MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982055385), received between Sep 16, 2024 and May 28, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PRODUCTS WERE UNABLE TO BE STERILIZED OR ASSEMBLED. IT WAS NOTED THERE WAS CHIPPING AND CRACKING, AND THEY WERE UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22098753 ↗MalfunctionMay 28, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PRODUCTS WERE UNABLE TO BE STERILIZED OR ASSEMBLED. IT WAS NOTED THERE WAS CHIPPING AND CRACKING, AND THEY WERE UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22098701 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT ON AUG 30, 2024 THE HEAD OF DEVICE BROKE INTRAOPERATIVELY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS WERE GENERATED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224896 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- 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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