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	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent surgery on (b)(6) 2026, during which bilateral 3.5 mm blade plates were used.Subsequently, one of the plates was reported to have fractured and was replaced with an lpf.

• 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
• Manufacturer (Section G): Orthopediatrics, Corp; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 50778280
• Report Number: 3006460162-2026-00048
• Device Sequence Number: 9791625
• Product Code: HRS
• UDI-Device Identifier: 00841132109717
• UDI-Public: 00841132109717
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 00-1200-1002
• Device Lot Number: 282738-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 37 LB