MAUDE Adverse Event Report: ORTHOPEDIATRICS VERTEGLIDE¿ 4.5 POLYAXIAL PEDICLE SCREW 4.5MM X 30MM, CLOSED

Model Number	00-1722-4530
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Prominent hardware: patient presented with upper thoracic screws on the left that are visible through skin.
Event or Problem Description
Prominent hardware - patient presented with upper thoracic screws on the left that are visible through skin.

• Brand Name: VERTEGLIDE¿ 4.5 POLYAXIAL PEDICLE SCREW 4.5MM X 30MM, CLOSED
• Common Device Name: VERTEGLIDE¿ 4.5 POLYAXIAL PEDICLE SCREW 4.5MM X 30MM, CLOSED
• 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: 24498371
• Report Number: 3006460162-2026-00010
• Device Sequence Number: 21327510
• Product Code: PGM
• UDI-Device Identifier: 00840194463508
• UDI-Public: 00840194463508
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K241816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/06/2026

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: 00-1722-4530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female