MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP SET SCREW, LARGE

Model Number	00-1003-4001
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Kyphosis case done around 4 years ago.Patient presents with broken rod.During revision, surgeons try to extend 1 level bilateral but surgeon blows pedicle on r so only extend on l but replace rods.During reduction, a lot of lordosis in rod.Patient comes back less than week later with set screw disengaged on the extended level.Add side by side to r side and replace disengaged set screw.

• Brand Name: SET SCREW, LARGE
• Common Device Name: SET SCREW, LARGE
• 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: 22490284
• Report Number: 3006460162-2025-00040
• Device Sequence Number: 20999940
• Product Code: NKB
• UDI-Device Identifier: 00841132100103
• UDI-Public: 00841132100103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/12/2025

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: 00-1003-4001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/12/2025
• 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
• Patient Sex: Male