MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM

Catalog Number	00-1300-0640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient arrived for 1yr post op follow up and upon reviewing x rays, surgeon noticed distal screw was broken.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• Common Device Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 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: 20903272
• Report Number: 3006460162-2024-00077
• Device Sequence Number: 15704678
• Product Code: NKB
• UDI-Device Identifier: 00841132100325
• UDI-Public: 00841132100325
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00-1300-0640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• 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 Sex: Unknown