MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.0 ROD, COCR, SINGLE HEX 500 MM

Model Number	00-1600-5055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) from (b)(6) reported a post-operative issue involving a 17-year-old male patient with cerebral palsy, implanted with two 5.0 cocr rods (part no.00-1600-5055) from the response 4.5/5.0 system.One rod was previously noted as broken but left in place due to the patient's stable condition.The patient later presented with a wound, and imaging revealed both rods were broken, with the second rod causing the injury.The breakage occurred at a non-fused section of the spine.The original implant date was (b)(6) 2023.

• Brand Name: 5.0 ROD, COCR, SINGLE HEX 500 MM
• Common Device Name: ROD, COCR, SINGLE HEX
• 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: 23077267
• Report Number: 3006460162-2025-00056
• Device Sequence Number: 14693992
• Product Code: NKB
• UDI-Device Identifier: 00841132150603
• UDI-Public: 00841132150603
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/17/2025

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: 00-1600-5055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Sex: Male