MAUDE Adverse Event Report: ORTHOPEDIATRICS PEDICLE SCREW DRIVER

Model Number	01-1003-6035
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the recent case, rep encountered a significant wobble issue that led to the discovery of a new distal tip engagement concern.Representative spent approximately 30 minutes or more at the back table, testing with 3-4 different drivers and loading screws.There was no visible degradation or damage to any distal tips, and the screws appeared to be in good condition.Despite this, the issue slowed the case considerably and introduced unnecessary stress and frustration for the surgical team.

• Brand Name: PEDICLE SCREW DRIVER
• Common Device Name: PEDICLE SCREW DRIVER
• 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: 23607407
• Report Number: 3006460162-2025-00073
• Device Sequence Number: 21133245
• Product Code: NKB
• UDI-Device Identifier: 00841132122549
• UDI-Public: 00841132122549
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/20/2025

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: 01-1003-6035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 68 KG