MAUDE Adverse Event Report: ORTHOPEDIATRICS 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE

Model Number	00-1200-1002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) from (b)(6) hospital reported a post-operative issue involving a trauma & deformity system, specifically an lcb blade plate (part number: 00-1200-1002, lot number: 241069-b), which had been in use for less than six months.The device was implanted in an 8-year-old female patient (initials (b)(6)) on (b)(6) 2025 and was removed on (b)(6) 2025, after the plate broke.The issue was discovered during a clinic visit post-operation.The broken device was scrapped and not returned for evaluation.

• Brand Name: 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE
• Common Device Name: 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOOEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 23380666
• Report Number: 3006460162-2025-00060
• Device Sequence Number: 15726207
• Product Code: HRS
• UDI-Device Identifier: 00841132109717
• UDI-Public: 00841132109717
• 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: 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): 10/24/2025

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?: No
• Device Model Number: 00-1200-1002
• Device Lot Number: 241069-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 8 YR
• Patient Sex: Female