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

Model Number	00-1300-2640
Medical Device Problem Code	Fracture (1260)
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
Patient underwent psf for ais.Suspect screw fracture noted on follow up in 2023 with no symptoms and no report from treating clinician.Obvious screw fracture noted on final follow up (today) patient remained un-symptomatic and discharged from surgeon care.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 40MM
• Common Device Name: 5.5/6.0 POLYAXIAL 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: 23533167
• Report Number: 3006460162-2025-00071
• Device Sequence Number: 9020927
• Product Code: NKB
• UDI-Device Identifier: 00841132101315
• UDI-Public: 00841132101315
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 00-1300-2640
• 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: 20 YR
• Patient Sex: Female