MAUDE Adverse Event Report: ORTHOPEDIATRICS 130° CANNULATED CHILD BLADE PLATE 40MM 0MM X 4 HOLE

Model Number	00-1200-5000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came to the hospital with severe pain, doctor sent for xray and at this point discovered that the plate was broken inside.

• Brand Name: 130° CANNULATED CHILD BLADE PLATE 40MM 0MM X 4 HOLE
• Common Device Name: 130° CANNULATED CHILD BLADE PLATE 40MM 0MM X 4 HOLE
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 24292456
• Report Number: 3006460162-2026-00003
• Device Sequence Number: 10247694
• Product Code: HRS
• UDI-Device Identifier: 00841132110287
• UDI-Public: 00841132110287
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1200-5000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown