NA 02.214.114Recalls & reported problems
Synthes GmbH · 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 14MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982055484), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2023Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT (B)(6) 2023 THE SURGEON HAD ISSUES WITH SCREWS GETTING PURCHASE IN THE BONE. IT'S POSSIBLE THAT THERE WAS A FRAGMENT THERE, HOWEVER IT WAS UNKNOWN. HE DECIDED TO LEAVE THE THIRD SCREW OUT BECAUSE HE FELT COMFORTABLE WITH THE FIXATION WITH TWO SCREWS. ADDITIONALLY WHEN THE FIRST 1.1 DRILL BIT WAS SELECTED BEFORE USE, IT WAS DETERMINED TO BE BENT. IT WAS REMOVED, AND ANOTHER DRILL BIT WAS USED SUCCESSFULLY. THE SURGERY WAS DELAYED FOR 5 MINUTES BUT IT WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WAS THERE. THIS REPORT IS FOR ONE (1) 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 14. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17836995 ↗
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- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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