MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 POLYAXIAL PEDICLE SCREWS - Ø6.5MM, 40MM LENGTH

Catalog Number	00-1300-7640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented approximately 14 months post op with broken screw bilaterally at the distal end on construct (t12).Fusion was not achieved so was forced to bring back to or, remove broken screw and extend fusion 1 level lower (l1) while also replacing rods bilaterally.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREWS - Ø6.5MM, 40MM LENGTH
• Common Device Name: 5.5/6.0 POLYAXIAL PEDICLE SCREWS - Ø6.5MM, 40MM LENGTH
• 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: 20701795
• Report Number: 3006460162-2024-00072
• Device Sequence Number: 14398570
• Product Code: NKB
• UDI-Device Identifier: 00841132131299
• UDI-Public: 00841132131299
• 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
• 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): 11/16/2024

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: 00-1300-7640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/16/2024
• 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: Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 50 KG