LCB 00-1200-2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132109731), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K110959, K260323); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Fracture; Fracture

  DR. (B)(6) FROM THE(B)(6) REPORTED A COMPLAINT INVOLVING A CONSIGNED, NON-STERILE "INFANT 2-HOLE" PLATE (PART NUMBER 00-1200-2001) FROM THE TRAUMA & DEFORMITY - LCB SYSTEM. THE ISSUE WAS DISCOVERED POST-OPERATIVELY VIA X-RAY, REVEALING A FRACTURE OF THE PLATE OVER THE CUT SITE. THE PATIENT, A MALE, HAD BEEN LYING ON HIS SIDE WITH HIS LEG ELEVATED AT THE TIME. ALTHOUGH THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR INJURY, THE DEVICE FAILURE NECESSITATED A REVISION PROCEDURE. THE IMPLANT WAS PLACED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2025. FRACTURED COMPONENTS ARE AVAILABLE AND WILL BE PROVIDED TO ENGINEERING FOR FURTHER ANALYSIS. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 22664173 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110959, K260323. One submission often covers many models, so check the product and lot details in each record.

• Z-1535-2013 · Apr 19, 2013 · Terminated
  90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractur
• Z-1534-2013 · Apr 19, 2013 · Terminated
  90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractur
• Z-1536-2013 · Apr 19, 2013 · Terminated
  90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractur