MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP LOCKING CANNULATED ADOLESCENT BLADE; 130 DEG LOCKING CANNULATED ADOLESCENT BLADE 60MM X 0MM X 4 HOLE

Model Number	00-1200-7003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After post op imaging and patient complaint on pain the surgeon discover plate breakage.

• Brand Name: LOCKING CANNULATED ADOLESCENT BLADE
• Common Device Name: 130 DEG LOCKING CANNULATED ADOLESCENT BLADE 60MM X 0MM X 4 HOLE
• 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: 22088060
• Report Number: 3006460162-2025-00030
• Device Sequence Number: 17874052
• Product Code: HRS
• UDI-Device Identifier: 00841132110362
• UDI-Public: 00841132110362
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 05/27/2025

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: 00-1200-7003
• Device Lot Number: 198133-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2025
• Initial Report FDA Received Date: 05/27/2025
• 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: Hospitalization; Other
• Patient Sex: Male