MAUDE Adverse Event Report: ORTHOPEDIATRICS CARRIAGE ASSEMBLY, MONORAIL

Model Number	810-12F
Medical Device Problem Code	Unintended Movement (3026)
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
A right humerus lengthening osteotomy was performed.Once they attempted to assemble the construct with the original pins, they rolled away.They were replaced with 600-20 bolts, but the construct still presented instability.The distraction and compression system did not move easily along the rail.However, the doctor tried to alleviate the positional load, but even manipulating the carriage outside the surgical field, it was difficult to advance or retract.They tried to continue with the half pins and the osteotomy.When stabilizing the two fragments, the half pin fixation screws rolled, losing the alignment of the osteotomy, which overlapped or shifted posteriorly.The team decided to change the initial configuration by placing the distractor proximally and adding an additional clamp on the distal part for a new half pin to improve the stability of the fragment.However, the team was still not satisfied with the result.Furthermore, the initial budget for the surgical approach was increased.A reoperation will likely be necessary.

• 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: 23532800
• Report Number: 3006460162-2025-00070
• Device Sequence Number: 10167191
• 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): 11/12/2025

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: 251538-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: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 38 KG