MAUDE Adverse Event Report: Orthopediatrics 4.5 MM X 44 MM CORTICAL SCREW

Model Number	10-1500-3044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury

• Brand Name: 4.5 MM X 44 MM CORTICAL SCREW
• Common Device Name: 4.5 MM X 44 MM CORTICAL SCREW
• 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: 50952148
• Report Number: 3006460162-2026-00055
• Device Sequence Number: 18525157
• Product Code: HRS
• UDI-Device Identifier: 00841132118290
• UDI-Public: 00841132118290
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K083726
• 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): 09/30/2026

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: 10-1500-3044
• Device Lot Number: 262321-G
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Unknown
• Patient Weight: 88 LB