MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5/5.0 REDUCTION POLYAXIAL PEDICLE SCREW DL 6.0MM X 40MM

Catalog Number	00-1300-3640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Broken screws at most distal level, l2.Had to skip this level for final fusion because shanks of broken screws had to stay in.Implant fractured.

• Brand Name: 4.5/5.0 REDUCTION POLYAXIAL PEDICLE SCREW DL 6.0MM X 40MM
• Common Device Name: 4.5/5.0 REDUCTION POLYAXIAL PEDICLE SCREW DL 6.0MM X 40MM
• 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: 21112589
• Report Number: 3006460162-2025-00002
• Device Sequence Number: 8719486
• Product Code: NKB
• UDI-Device Identifier: 00841132153444
• UDI-Public: 00841132153444
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/09/2025

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: 00-1300-3640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/09/2025
• 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
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 45 KG