MAUDE Adverse Event Report: ORTHOPEDIATRICS 3.5 MM BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT

Model Number	00-1050-3210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Plate broke soon after placement.Pt was a 7 y/o male 60kg, and was non-compliant with post op instructions and began weight bearing two day post-op.Pt stated he bent over in a seated position and felt a pop.Pt was fixed wing transported to our facility and the hardware was removed and replaced with two ss 3.5mm flex nails.

• Brand Name: 3.5 MM BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT
• Common Device Name: 3.5 MM BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOOEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 22910080
• Report Number: 3006460162-2025-00049
• Device Sequence Number: 9110912
• Product Code: HRS
• UDI-Device Identifier: 00841132109366
• UDI-Public: 00841132109366
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 08/27/2025

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: 00-1050-3210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 60 KG