CHS 3571129244Recalls & reported problems
Smith & Nephew, Inc. · 4.5MM X 44MM CORTICAL BONE SCREW SELF-TAPPING STAINLESS STEEL · Class 2 · Implant
All models of CHS (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010551887), received between Jul 27, 2021 and Jul 27, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Insert” (2 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 16, 2026.
Most reported problems
Device problems
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2021Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT, DURING A THR, TWO (2) 4.5MM X 44MM CORT BONE SCR ST SST AND TWO (2) 4.5MM X 42MM CORT BONE SCR ST SST, WERE DIFFICULT TO START INSERTION OF A CHS 4 HOLE 130 DEG PLATE. SURGEON STATED THAT THE DRILL HOLE HAD BEEN PLACED IN FREEHAND, THEREFORE WAS TOO CLOSE TO THE PLATE FOR THE SCREW TO BITE EVENLY. THE PROCEDURE WAS COMPLETED WITH THE SAME REPORTED SCREWS. HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAYED OR NOT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233247 ↗InjuryJul 27, 2021Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT, DURING A THR, TWO (2) 4.5MM X 44MM CORT BONE SCR ST SST AND TWO (2) 4.5MM X 42MM CORT BONE SCR ST SST, WERE DIFFICULT TO START INSERTION OF A CHS 4 HOLE 130 DEG PLATE. SURGEON STATED THAT THE DRILL HOLE HAD BEEN PLACED IN FREEHAND, THEREFORE WAS TOO CLOSE TO THE PLATE FOR THE SCREW TO BITE EVENLY. THE PROCEDURE WAS COMPLETED WITH THE SAME REPORTED SCREWS. HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAYED OR NOT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233213 ↗
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- 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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