MAUDE Adverse Event Report: Orthopediatrics 3P¿ SM 3.5mm Non-Locking Screw, T15, 16mm

Model Number	00-3135-0016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
3.5 cortical screw went through hole of the 3.5 plate causing a revision.

• Brand Name: 3P¿ SM 3.5mm Non-Locking Screw, T15, 16mm
• Common Device Name: 3P¿ SM 3.5mm Non-Locking Screw, T15, 16mm
• 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: 50793062
• Report Number: 3006460162-2026-00052
• Device Sequence Number: 13122415
• Product Code: HWC
• UDI-Device Identifier: 00840194419796
• UDI-Public: 00840194419796
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 00-3135-0016
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown