MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 POLYAXIAL PEDICLE SCREW; 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	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) at (b)(6) reported a post-operative issue involving a 6.0x40 poly pedicle screw (part number 00-1300-2640) from the response 5.5_6.0 scoliosis system.The non-sterile, consigned device was implanted on (b)(6) 2024, and was later found broken at the shank during a one-year follow-up in the clinic.Despite the breakage, there was no patient injury, no delay in surgery, and no need for revision; the procedure was completed successfully.The broken piece remains inside the patient, and no product was returned for evaluation.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW
• 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): ORTHOOEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 22742785
• Report Number: 3006460162-2025-00044
• Device Sequence Number: 7404557
• Product Code: NKB
• UDI-Device Identifier: 00841132101315
• UDI-Public: 00841132101315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/07/2025

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: 07/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown