Nex-D2 CBEAJ-55040Recalls & reported problems
Next Orthosurgical, Inc. · VARIABLE CROSS LINK, 40-56MM · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840314120366), received between Jan 20, 2026 and Jan 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Fracture
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.
Patient problems: Insufficient Information
MAUDE report 24119159 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.