OrthoPediatrics Titanium PediPlates System 00-1015-8024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841132144749), received between Mar 26, 2020 and Aug 8, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Fracture; Fracture

  THE PROXIMAL SCREWS ON BOTH THE LEFT AND RIGHT SIDE BROKE AT THE JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22764414 ↗
• MalfunctionMay 6, 2025Fracture; Fracture

  SITUATION: SIX OUT OF SIX SCREW HEADS WERE DEFORMED DURING EXTRACTION. ALL SCREWS, INCLUDING THE DEFORMED SCREW HEADS, WERE REMOVED USING A HOSPITAL-OWNED CARBIDE DRILL AND OTHER TOOLS. SURGEON'S COMMENT: I CONSIDER THAT THERE MAY HAVE BEEN A STRUCTURAL OR DESIGN PROBLEM WITH THE PRODUCT IN QUESTION, WHICH MAY HAVE CAUSED THIS EVENT. DELAYS IN SURGERY: THERE WAS A DELAY OF APPROXIMATELY TWO HOURS. PATIENT'S POST-OPERATIVE COURSE: IT WAS GOOD AND UNEVENTFUL AND THE PATIENT WAS DISCHARGED ON THE SECOND POST-OPERATIVE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969513 ↗
• MalfunctionJan 26, 2025Fracture; Fracture

  ON (B)(6) 2021, IMPLANTS WERE PLACED IN A TOTAL OF FOUR LOCATIONS ON THE DISTAL MEDIAL AND LATERAL SIDES OF THE RIGHT FEMUR AND ON THE PROXIMAL MEDIAL SIDE OF THE RIGHT AND LEFT TIBIA AS GROWTH CONTROL SURGERY AT THE MEDICAL INSTITUTION. THE IMPLANTS WERE SUBSEQUENTLY REMOVED ON (B)(6) 2024, SOME THREE YEARS LATER. AT THAT TIME, THE FOLLOWING DEFECTS OCCURRED. A TOTAL OF EIGHT SCREWS WERE ATTEMPTED TO BE REMOVED USING A HEXAGONAL SCREWDRIVER. OF THE EIGHT SCREWS, SIX SCREWS COULD NOT BE REMOVED BECAUSE THEIR HEADS WERE DEFORMED OR BROKEN DURING THE REMOVAL OPERATION. THEREFORE, A CARBIDE DRILL WAS USED TO DESTROY THE HEADS OF THE SIX SCREWS THAT WERE DEFORMED OR BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 21238201 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING A PLANNED REMOVAL OF CANNULATED SCREWS, TWO SCREWS FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884012 ↗