MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREWS - Ø5.5MM, 40MM LENGTH

Model Number	00-1300-6540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Implanted date is estimated as was only told by surgeon they are 1 year post op.Patient underwent posterior spinal fusion approximately 1 year ago and came back for their 1yr follow up and complained of pain.Surgeon took x rays and found broken screw at l2.Surgeons do not want to re-operate but may have to due to patient complaining of pain.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREWS - Ø5.5MM, 40MM LENGTH
• Common Device Name: 5.5/6.0 UNIAXIAL PEDICLE SCREWS - Ø5.5MM, 40MM LENGTH
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 22328147
• Report Number: 3006460162-2025-00035
• Device Sequence Number: 9583092
• Product Code: NKB
• UDI-Device Identifier: 00841132130551
• UDI-Public: 00841132130551
• 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: 2025
• 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): 06/25/2025

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: 00-1300-6540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female