MAUDE Adverse Event Report: ORTHOPEDIATRICS 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 55 MM

Model Number	00-0903-2655
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Three days post-operation, the patient moved, and follow-up x-rays revealed significant backing out of the z-hole locking screw, with the proximal femur/head having displaced from the distal femur.A revision procedure was required to restore alignment between the proximal and distal femur.During the revision, the existing proximal screws were replaced, and it was noted that the removed screws were substantially bent.

• Brand Name: 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 55 MM
• Common Device Name: 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 55 MM
• 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: 23837947
• Report Number: 3006460162-2025-00083
• Device Sequence Number: 4993182
• Product Code: HWC
• UDI-Device Identifier: 00841132111055
• UDI-Public: 00841132111055
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 00-0903-2655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Female