MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 POLYAXIAL PEDICLE SCREW; 5.5/6.0 POLYAXIAL PEDICLE SCREWS - Ø6.5MM, 40MM LENGTH

Model Number	00-1300-7640
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) hospital reported a post-operative issue involving a 6.5x40mm poly pedicle screw (part number 00-1300-7640) 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 inside the patient during a clinic visit 10 months post-op.Despite the breakage, there was no patient injury, surgical delay, or need for revision, and the surgery was completed successfully.The broken screw remains inside the patient, and no product is available for return or evaluation.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW
• Common Device Name: 5.5/6.0 POLYAXIAL PEDICLE SCREWS - Ø6.5MM, 40MM LENGTH
• 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: 22742839
• Report Number: 3006460162-2025-00045
• Device Sequence Number: 7534137
• Product Code: NKB
• UDI-Device Identifier: 00841132131299
• UDI-Public: 00841132131299
• 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: 00-1300-7640
• 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