MAUDE Adverse Event Report: Orthopediatrics VERTEGLIDE¿ 5.5 POLYAXIAL PEDICLE SCREW 5.0MM X 35MM, CLOSED

Model Number	00-1724-5035
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury

• Brand Name: VERTEGLIDE¿ 5.5 POLYAXIAL PEDICLE SCREW 5.0MM X 35MM, CLOSED
• Common Device Name: VERTEGLIDE¿ 5.5 POLYAXIAL PEDICLE SCREW 5.0MM X 35MM, CLOSED
• Manufacturer (Section D): Orthopediatrics; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): Orthopediatrics, Corp; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 50793060
• Report Number: 3006460162-2026-00051
• Device Sequence Number: 9443189
• Product Code: PGM
• UDI-Device Identifier: 00840194464512
• UDI-Public: 00840194464512
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 00-1724-5035
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 41 LB