MAUDE Adverse Event Report: NEXT ORTHOSURGICAL NEX-D2 POSTERIOR FIXATION SYSTEM, VARIABLE CROSS LINK (40-56 MM); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	CBEAJ-55040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Next orthosurgical inc.Conducted a complaint investigation for the reported malfunction involving a variable cross link (40-56 mm), model cbeaj-55040, lot u006308b, a component of the nex-d2 posterior fixation system.The manufacturer became aware of the event on june 3, 2024.The complaint reported that during a re-operation performed on (b)(6) 2024, the cross-link beam fractured at the base of the gripping section, and the hooked/grasping portion could not be removed from the spinal rod after the set screw was removed.The surgical procedure was completed with the gripping portion remaining in situ.The patient recovered, and no death, life-threatening condition, or permanent impairment was reported.The investigation included review of the device history record, which confirmed that the device met applicable inspection and release criteria.An existing nonconforming material record related to incorrect size/laser marking was identified; however, this nonconformance was determined not to be related to the reported fracture failure mode.Evaluation of the returned device confirmed fracture of the cross-link beam at the base of the gripping section.Fracture surface characteristics were consistent with long-term mechanical fatigue and stress concentration associated with extended in vivo use (approximately five years).No evidence was identified that the fracture was caused by a manufacturing process deviation, design inadequacy, labeling deficiency, or user error.Historical complaint data and trend analysis did not identify an increase in similar events.Based on the investigation, the event was concluded to be a component-level mechanical failure occurring over extended implant duration, consistent with known and documented device risks.No corrective or preventive action was deemed necessary at this time.This event is being reported as a device malfunction, as recurrence of a similar failure could potentially result in patient injury, although no injury occurred in this case.
Event or Problem Description
On (b)(6) 2024, during a re-operation on a patient who previously underwent l3-l5 spinal fixation in 2019, a variable cross link (40-56 mm) was removed.During removal, the cross-link beam fractured, and the hooked/grasping end of the beam could not be removed from the spinal rod, even after the cross-link set screw was removed.As a result, the surgical procedure was completed with the grasping portion of the device remaining in situ.The patient recovered, and no death, life-threatening condition, or permanent impairment was reported.

• Brand Name: NEX-D2 POSTERIOR FIXATION SYSTEM, VARIABLE CROSS LINK (40-56 MM)
• 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: 24119159
• Report Number: 3010020754-2026-00002
• Device Sequence Number: 6050518
• Product Code: NKB
• UDI-Device Identifier: 00840314120366
• UDI-Public: (01)00840314120366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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: CBEAJ-55040
• Device Lot Number: U006308B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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