MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 45MM; POLYAXIAL REDUCTION PEDICLE SCREW

Model Number	00-1300-0645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6) from chicago shrine reported an issue involving a 12-year-old female patient implanted with a 6.0 uni pedicle screw (part no.00-1300-0645) from the response 5.5/6.0 spine system.During a 12-month follow-up, two screws were found broken at the bottom of the construct.The event resulted in a revision procedure.The affected device was removed on (b)(6) 2025.No patient injury or death was reported.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 45MM
• Common Device Name: POLYAXIAL REDUCTION PEDICLE SCREW
• 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: 23077538
• Report Number: 3006460162-2025-00058
• Device Sequence Number: 17304435
• Product Code: NKB
• UDI-Device Identifier: 00841132100332
• UDI-Public: 00841132100332
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 09/17/2025

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: 00-1300-0645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 12 YR
• Patient Sex: Female