MAUDE Adverse Event Report: ORTHOPEDIATRICS 130° CANNULATED ADOLESCENT BLADE PLATE 70MM X 0MM X 4 HOLE

Model Number	00-1200-7005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient has been experiencing several cracking sounds for several weeks.There is no date for the new surgery at the moment.
Event or Problem Description
The patient has been experiencing several cracking sounds for several weeks.There is no date for the new surgery at the moment.

• Brand Name: 130° CANNULATED ADOLESCENT BLADE PLATE 70MM X 0MM X 4 HOLE
• Common Device Name: 130° CANNULATED ADOLESCENT BLADE PLATE 70MM X 0MM X 4 HOLE
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 24292454
• Report Number: 3006460162-2026-00006
• Device Sequence Number: 10247692
• Product Code: HRS
• UDI-Device Identifier: 00841132110386
• UDI-Public: 00841132110386
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 00-1200-7005
• Device Lot Number: 271055-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female