MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM

Model Number	00-1300-0640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, orthopediatrics corp.Received a complaint involving a 6.0 x 40 mm pedicle screw (p/n 00-1300-0640, lot 246588-m) used during a scoliosis procedure at (b)(6) hospital.The pedicle screw shaft fractured post op.The surgeon reported that the tulip and a portion of the shaft were retrieved; however, a portion of the fractured device remained in the patient.The event required a revision procedure.The procedure was subsequently completed successfully.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• Common Device Name: 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• 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: 25184466
• Report Number: 3006460162-2026-00024
• Device Sequence Number: 10702163
• Product Code: NKB
• UDI-Device Identifier: 00841132100325
• UDI-Public: 00841132100325
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 05/15/2026

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: 00-1300-0640
• Device Lot Number: 246588-M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown