MAUDE Adverse Event Report: NEXT ORTHOSURGICAL NEX-D2, SET SCREW, BLUNT START, T-30 HEXALOBE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	CBCAJ-10000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who underwent spinal surgery on (b)(6) 2024, was later found to have dislocation of the l4 right set screw associated with the implanted pedicle screw system.On (b)(6) 2025, the treating physician confirmed the dislocation.As a result, a second surgical intervention was performed on (b)(6), 2025, during which the l4 right pedicle screw, set screw, rod, and the l5 right rod and set screw were removed.The l4 pedicle screw was replaced with an upsized 7.8 ã 50 mm pedicle screw, and final fixation was achieved using a new rod and set screw.The re-operation was completed successfully.No device sample was available for return or evaluation.
Additional Manufacturer Narrative
Next orthosurgical inc.Received a complaint on (b)(6) 2025, reporting that a patient who underwent lumbar spinal surgery on (b)(6) 2024, was later found to have dislodgement of an implanted set screw associated with a thoracolumbosacral pedicle screw system at the l4 level.The dislodgement was confirmed by the treating physician on (b)(6) 2025.A revision surgery was performed on (b)(6) 2025, during which the affected pedicle screw, set screw, and rod were removed and replaced with an upsized pedicle screw and new rod and set screw.The revision surgery was completed successfully.The affected component was identified as a set screw, blunt start (part no.Cbcaj-10000), lot no.003552a03.The device history record for the affected lot was reviewed and confirmed that the product met all applicable inspection and release criteria.No physical device sample was returned for evaluation, and there was no remaining inventory available from the affected lot to permit additional physical inspection or material analysis.As a result, the specific failure mechanism could not be conclusively confirmed.Images provided with the original complaint showed surface markings such as fading and abrasion, which can occur during surgical use.No indications of breakage were observed at the threads of either the pedicle screw tulip or the set screw.Based on predominantly clinical information provided in the original complaint, the event may be related to procedural factors; however, this could not be confirmed.Although no product malfunction was verified, the event met the criteria for medical device reporting due to the requirement for additional surgical intervention and is being reported in accordance with 21 cfr part 803.No corrective or preventive action was initiated.The complaint will be closed based on the information currently available.The manufacturer will continue to monitor similar events through post-market surveillance and trending, and the complaint record will be updated if additional information becomes available.

• Brand Name: NEX-D2, SET SCREW, BLUNT START, T-30 HEXALOBE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEXT ORTHOSURGICAL; 3270 corporate view; ste a; vista CA 92081
• Manufacturer (Section G): NEXT ORTHOSURGICAL; 3270 corporate view; suite; vista CA 92081
• Manufacturer Contact: yusuke nakamura ; 3270 corporate view; suite a; vista, CA 92081
• MDR Report Key: 24119160
• Report Number: 3010020754-2026-00001
• Device Sequence Number: 20346266
• Product Code: NKB
• UDI-Device Identifier: 00840314141798
• UDI-Public: (01)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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CBCAJ-10000
• Device Lot Number: 003552A03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown