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Piccolo Composite Plate System Distal Femur Plate (REF DFELN1810)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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109335230), received between Aug 31, 2017 and Aug 31, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 18, 2026.

Most reported problems

Device problems

  • Failure To Adhere Or Bond2
  • Manufacturing, Packaging or Shipping Problem2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2017Failure To Adhere Or Bond; Manufacturing, Packaging or Shipping Problem; Failure To Adhere Or Bond; Manufacturing, Packaging or Shipping Problem

    DURING OPERATION, IT WAS DIFFICULT TO CONNECT A PICCOLO COMPOSITE DISTAL FEMUR PLATE AND ITS HANDLE (OUTSIDE THE PATIENT BODY). ANOTHER PLATE WAS USED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6833780 ↗
  • MalfunctionAug 31, 2017Failure To Adhere Or Bond; Manufacturing, Packaging or Shipping Problem; Failure To Adhere Or Bond; Manufacturing, Packaging or Shipping Problem

    DURING OPERATION, IT WAS DIFFICULT TO CONNECT A PICCOLO COMPOSITE DISTAL FEMUR PLATE AND ITS HANDLE (OUTSIDE THE PATIENT BODY). NEVERTHELESS, THE PHYSICIAN SUCCEEDED TO CONNECT THE INSERTION HANDLE TO THE PLATE, AND THE PLATE WAS SATISFACTORILY IMPLANTED. IT WAS NOTED THAT THE TANTALUM WIRE DID NOT EXTEND THROUGH THE ENTIRE PLATE PERIMETER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6833779 ↗

Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices

All Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices →

Sources and updates

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