Piccolo Composite Plate System Distal Femur Plate (REF DFELN1816)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
- 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 07290109335292), received between Nov 18, 2019 and Jul 30, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTAL FEMUR PLATE WAS IMPLANTED (IN ITALY) TO TREAT A PATHOLOGICAL FRACTURE (A PF NAIL AND BONE GRAFT WERE ALSO IMPLANTED IN THE SAME BONE). ABOUT TWO YEARS LATER, X-RAYS REVEALED NONUNION WITH DISCONNECTION OF PLATE SHAFT' DISTAL END FROM ONE SCREW. A REVISION SURGERY WAS PERFORMED IN WHICH THE PLATE WAS REMOVED AND REPLACED WITH A MEDIAL PLATE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 10343589 ↗InjuryNov 18, 2019Fracture; Fracture
A DISTAL FEMUR PLATE WAS IMPLANTED (IN THE (B)(6)), TO TREAT A PATHOLOGICAL FRACTURE (A METASTASIS WAS DIAGNOSED), REPLACING AN EXTERNAL FIXATION. APPROXIMATELY 4.5 MONTHS AFTER IMPLANTATION, THE PLATE BROKE. THE PLATE WAS REMOVED AND REPLACED BY A TITANIUM RETROGRADE FEMORAL NAIL.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 9334902 ↗
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- 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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