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

Model Number	00-1003-4001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), dr.(b)(6) started to implant response 6.0 into a patient.Due to patient health issues the case was aborted with about half the screws implanted.He then came back on (b)(6) and completed the surgery which included levels t2 to l2.On (b)(6), dr.(b)(6) revised the patient due to the lower set screws having fallen out.After exposing he found that nine of the lower 10 set screws were loose or missing.He was very concerned about the screws loosening farther proximal in the construct.He said he understands the bottom to loosening, but did not understand why they loosened the rest of the way up.He would like to talk to somebody about testing whether burning or cutting the rod insitu has the potential to loosen the rod.

• 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: 22290319
• Report Number: 3006460162-2025-00031
• Device Sequence Number: 18208596
• Product Code: NKB
• UDI-Device Identifier: 00841132100103
• UDI-Public: 00841132100103
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 06/18/2025

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: 00-1003-4001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/19/2025
• 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: 14 YR
• Patient Sex: Female