MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM

Model Number	00-1300-0640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came back to clinic for 1 year follow up and surgeon noticed screw at liv broke mid shaft.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• Common Device Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• 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: 23648620
• Report Number: 3006460162-2025-00076
• Device Sequence Number: 9961343
• Product Code: NKB
• UDI-Device Identifier: 00841132100325
• UDI-Public: 00841132100325
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/25/2025

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: 00-1300-0640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown