MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP SET SCREWS; LRG. SET SCREWS

Catalog Number	00-1003-4001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon noticed that set screws had back outed and has subsequently revised.This was surgeons first case either response, and did not use the reduction tower at the bottom of the construct.Handles torque were returned and found to be in calibration.

• Brand Name: SET SCREWS
• Common Device Name: LRG. SET SCREWS
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 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: 21333255
• Report Number: 3006460162-2025-00006
• Device Sequence Number: 8128492
• Product Code: NKB
• UDI-Device Identifier: 00841132100103
• UDI-Public: 00841132100103
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/07/2025

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 Catalogue Number: 00-1003-4001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 44 KG