Piccolo Composite Plate System Distal Femur Plate (REF DFERN1816)Recalls & reported problems
Carbofix Orthopedics Ltd · A plate inindicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extraarticular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. · Class 2 · Implant
Data updated Oct 18, 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 07290109335308), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Limb Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Fracture; Fracture
THE PATIENT SUFFERED A STANDING LEVEL FALL RESULTING IN A COMMINUTED DISTAL FEMUR FRACTURE. DUE TO FRACTURE PATTERN AND RECENT APIXABAN USE, THE PATIENT WAS INITIALLY TREATED WITH EXTERNAL FIXATION. SIX DAYS LATER, EXTERNAL FIXATION WAS REMOVED AND CARBOFIX DISTAL FEMUR PLATE AND SCREWS WERE IMPLANTED. THE PATIENT WAS PERMITTED TO WEIGHT BEAR AS TOLERATED. X-RAY TAKEN 7 DAYS POST-PLATE IMPLANTATION INDICATED THAT THE PLATE WAS FRACTURED. A WEEK LATER THE PLATE AND SCREWS WERE REMOVED IN A REVISION SURGERY AND BOTH RETROGRADE INTRAMEDULLARY FEMORAL NAIL AND TITANIUM DISTAL FEMUR PLATE WERE IMPLANTED.
Patient problems: Limb Fracture
MAUDE report 13535021 ↗
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- 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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