MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 90 DEG LOCKING CANNULATED INFANT BLADE 30MM X 5MM X 2 HOLE

Model Number	00-1200-2001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) from the(b)(6) reported a complaint involving a consigned, non-sterile "infant 2-hole" plate (part number 00-1200-2001) from the trauma & deformity - lcb system.The issue was discovered post-operatively via x-ray, revealing a fracture of the plate over the cut site.The patient, a male, had been lying on his side with his leg elevated at the time.Although the surgery was completed successfully without delay or injury, the device failure necessitated a revision procedure.The implant was placed on (b)(6) 2025 and removed on (b)(6) 2025.Fractured components are available and will be provided to engineering for further analysis.No broken pieces were left inside the patient.

• Brand Name: 90 DEG LOCKING CANNULATED INFANT BLADE 30MM X 5MM X 2 HOLE
• Common Device Name: 90 DEG LOCKING CANNULATED INFANT BLADE 30MM X 5MM X 2 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: 22664173
• Report Number: 3006460162-2025-00042
• Device Sequence Number: 3716554
• Product Code: HRS
• UDI-Device Identifier: 00841132109731
• UDI-Public: 00841132109731
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/30/2025

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: 00-1200-2001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/30/2025
• 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: Required Intervention; Other
• Patient Sex: Male