MAUDE Adverse Event Report: ORTHOPEDIATRICS SET SCREW, LARGE

Model Number	00-1003-4001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A post-operative device-related issue was identified in a patient who underwent spinal surgery on (b)(6) 2024, utilizing a response 5.5/6.0 scoliosis system.The implanted device included a large set screw (part number: 00-1003-4001).On (b)(6) 2026, during a routine clinic follow-up visit, the patient presented with a disengaged set screw.The event was discovered in a post-operative clinical setting.There was no reported death or patient injury associated with this event; however, the disengagement resulted in the failure of the original surgical construct.As a result of this device issue, a revision surgery has been deemed necessary, and scheduling is pending.At this time the device remains implanted in the patient, and therefore, no product is currently available for return or evaluation.

• Brand Name: SET SCREW, LARGE
• Common Device Name: SET SCREW, LARGE
• 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: 25241560
• Report Number: 3006460162-2026-00026
• Device Sequence Number: 13161126
• Product Code: NKB
• UDI-Device Identifier: 00841132100103
• UDI-Public: 00841132100103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/21/2026

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: 00-1003-4001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown