MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP S-ROD, Ø 5.5MM COCR, 500MM, 50MM STRAIGHT

Model Number	00-1600-0040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hl rod broke intra-operatively on two separate occasions while surgeon was using coronal benders to achieve correction.It broke once at bottom of the construct and again at the middle of the construct.It was then replaced with s-rod and the same thing happened- it broke while he was coronal bending near the bottom of the construct.An open/closed wedding band was then used to attach broken piece of rod in order to avoid replacing full rod again.

• Brand Name: S-ROD, Ø 5.5MM COCR, 500MM, 50MM STRAIGHT
• Common Device Name: S-ROD, Ø 5.5MM COCR, 500MM, 50MM STRAIGHT
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 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: 22304831
• Report Number: 3006460162-2025-00033
• Device Sequence Number: 18332777
• Product Code: NKB
• UDI-Device Identifier: 00841132145890
• UDI-Public: 00841132145890
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/22/2025

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: 00-1600-0040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 13 YR
• Patient Sex: Male