MAUDE Adverse Event Report: ORTHOPEDIATRICS CARRIAGE ASSEMBLY, MONORAIL

Model Number	810-12F
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) noted that carriages had sliding problems.This caused a delay greater than 30 minutes.

• Brand Name: CARRIAGE ASSEMBLY, MONORAIL
• Common Device Name: CARRIAGE ASSEMBLY, MONORAIL
• 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: 23490830
• Report Number: 3006460162-2025-00069
• Device Sequence Number: 20007345
• Product Code: KTT
• UDI-Device Identifier: 00840194411189
• UDI-Public: 00840194411189
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/06/2025

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: 810-12F
• Device Lot Number: 236154-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 31 KG