MAUDE Adverse Event Report: Orthopediatrics 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 34 MM

Model Number	00-1005-4034
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: 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 34 MM
• Common Device Name: 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 34 MM
• 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: 50952151
• Report Number: 3006460162-2026-00056
• Device Sequence Number: 9534447
• Product Code: HWC
• UDI-Device Identifier: 00841132131756
• UDI-Public: 00841132131756
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K140431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 00-1005-4034
• Device Lot Number: 188762-A
• 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: 11 YR
• Patient Sex: Unknown
• Patient Weight: 92 LB