LARGE CANNULATED SCREWS 121640Recalls & reported problems
Smith & Nephew, Inc. · 6.5MM UNIVERSAL CANNULATED SCREW 100MM · Class 2 · Implant
All models of LARGE CANNULATED SCREWS (21)
Data updated Oct 18, 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 03596010063953), received between Dec 15, 2017 and Oct 25, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Injury1
- Loss of Range of Motion1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A FEMORAL FRACTURE WITH LARGE CANNULATED SCREWS, THE PATIENT SUSTAINED NON-UNION OF THE FRACTURE AN REQUIRED CONVERSION TO AN HEMIARTHROPLASTY. A SPECIFIC DATE FOR THE CONVERSION SURGERY IS NOT AVAILABLE. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT REMAIN ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 15665552 ↗InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO REMOVE THE TWO SCREWS FOR UNSPECIFIED REASONS.
Patient problems: Injury
MAUDE report 7121864 ↗
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- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive 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-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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