MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 POLYAXIAL PEDICLE SCREW 5.0MM X 40MM

Model Number	00-1300-2540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor removed two 5.5x40mm poly pedicle screws from l1, left and right.Screw was broke at the proximal ends of the screw shank.The broken hardware was removed.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW 5.0MM X 40MM
• Common Device Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW 5.0MM 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: 25364723
• Report Number: 3006460162-2026-00028
• Device Sequence Number: 13424501
• Product Code: NKB
• UDI-Device Identifier: 00841132101209
• UDI-Public: 00841132101209
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 06/02/2026

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: 00-1300-2540
• Device Lot Number: 263730-N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female