MAUDE Adverse Event Report: NEXT ORTHOSURGICAL NEX-D2; SET SCREW, BLUNT START

Model Number	CBCAJ-10000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Migration (4003)
Health Effect - Clinical Codes	Spinal Column Injury (2081); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned, dhr reviewed and no defect found, markings in photos provided by the reporter provide evidence that this was caused by a lack of engagement when tightening the screw.Surgical procedure technique issue / lack of properly following instructions for use.
Event or Problem Description
On (b)(6) 2024, an initial operation was performed on a patient externally fixating the l4-l5 vertebrae using pedicle screws.Then on (b)(6) 2025, the doctor confirmed that the l4 right set screw was dislocated.A reoperation was performed on (b)(6) 2025 and the l4 right pedicle screw, set screw, rod, and the l5 right set screw were removed.The pedicle screw was replaced with a larger od using screw size 7.8 x 50 mm.The original pedicle screw size used was a 7.0 x 50 mm.A new rod and set screws were implanted.

• Brand Name: NEX-D2
• Common Device Name: SET SCREW, BLUNT START
• Manufacturer (Section D): NEXT ORTHOSURGICAL; 3270 corporate view; suite a; vista CA 92081
• Manufacturer (Section G): NEXT ORTHOSURGICAL; 3270 corporate view; suite a; vista CA 92081
• Manufacturer Contact: misty calkins ; 3270 corporate view; suite a; vista, CA 92081 ; 7602953600
• MDR Report Key: 22464873
• Report Number: 3010020754-2025-00001
• Device Sequence Number: 17170392
• Product Code: NKB
• UDI-Device Identifier: 00840314141798
• UDI-Public: 00840314141798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CBCAJ-10000
• Device Catalogue Number: CBCAJ-10000
• Device Lot Number: 003552A03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian