Piccolo Composite Plate System Proximal Humerus PlateRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109333465), received between Dec 21, 2015 and May 11, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

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

• InjuryMay 11, 2016Fracture; Fracture

  THE INVOLVED PRODUCT (PROXIMAL HUMERUS PLATE) WAS IMPLANTED ON (B)(6) 2015 DURING A THIRD SURGERY (REVISION). BASED ON INFORMATION PROVIDED TO THE COMPANY, THE PREVIOUS, REMOVED, IMPLANTS (OF OTHER COMPANIES) WERE STAINLESS STEEL PLATE; AND TITANIUM NAIL AND CAGE (MESH). THE CARBOFIX PLATE WAS IMPLANTED WITH ALLOGRAFT, AFTER PARTIAL RESECTION OF THE EFFECTED HUMERAL BONE. ABOUT 12 WEEKS AFTER POST-OP., THE PATIENT COMPLAINED OF PAIN AND DISCHARGE AT THE SURGERY SITE. IN X-RAYS THE PLATE WAS SEEN BROKEN (AT THE AREA BETWEEN THE PLATE HEAD AND SHAFT). THE PATIENT UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2016. DURING THIS SURGERY, THE INVOLVED PLATE WAS REMOVED AND REPLACED BY TWO STAINLESS STEEL DIAPHYSEAL PLATES (POSITIONED AROUND THE HUMERUS IN 90 DEGREES TO EACH OTHER).

  Patient problems: Fracture, Arm; Nonunion/Delayed-union Bone Fracture

  MAUDE report 5646166 ↗
• InjuryDec 21, 2015Fracture

  THE INVOLVED PLATE WAS IMPLANTED IN A PATIENT FOLLOWING 20 FT FALL AND RIGHT PROXIMAL HUMERUS SHAFT FRACTURE. BASED ON SERIES OF INTRA-OPERATIVE X-RAYS, 4 SCREWS WERE IMPLANTED TO FIXATE THE FRAGMENTS PRIOR TO PLATE PLACEMENT; THEN, THE PLATE WAS IMPLANTED AND SECURED TO THE BONE USING ADDITIONAL SCREWS.

  Patient problems: Fall

  MAUDE report 5331902 ↗