neon™ superior spine system CS 1401-30TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04052536002863), received between Dec 13, 2021 and Dec 13, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2021Fracture; Fracture

  INITIAL SURGERY (B)(6) 2020, COMPLETE INSTRUMENTATION CAN BE SEEN IN THE IMAGE MADE DURING THE SURGERY. AFTER THE SURGERY PATIENT HAD A GOOD RECOVERY. ACCORDING TO PATIENT, RESTRICTIONS WERE FOLLOWED. ON (B)(6) 2021, A FRACTURE IN NEON WAS DETECTED IN MR. PATIENT IS WELL, WAITING TO KNOW THE NEXT STEPS. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12984418 ↗
• InjuryDec 13, 2021Fracture; Fracture

  INITIAL SURGERY (B)(6) 2020, COMPLETE INSTRUMENTATION CAN BE SEEN IN THE IMAGE MADE DURING THE SURGERY. AFTER THE SURGERY PATIENT HAD A GOOD RECOVERY. ACCORDING TO PATIENT, RESTRICTIONS WERE FOLLOWED. ON (B)(6) 2021, A FRACTURE IN NEON WAS DETECTED IN MR. PATIENT IS WELL, WAITING TO KNOW THE NEXT STEPS. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12984415 ↗
• MalfunctionDec 13, 2021Fracture; Fracture

  INITIAL SURGERY (B)(6) 2020, COMPLETE INSTRUMENTATION CAN BE SEEN IN THE IMAGE MADE DURING THE SURGERY. AFTER THE SURGERY PATIENT HAD A GOOD RECOVERY. ACCORDING TO PATIENT, RESTRICTIONS WERE FOLLOWED. ON (B)(6) 2021, A FRACTURE IN NEON WAS DETECTED IN MR. PATIENT IS WELL, WAITING TO KNOW THE NEXT STEPS. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12984407 ↗
• MalfunctionDec 13, 2021Fracture; Fracture

  INITIAL SURGERY (B)(6) 2020, COMPLETE INSTRUMENTATION CAN BE SEEN IN THE IMAGE MADE DURING THE SURGERY. AFTER THE SURGERY PATIENT HAD A GOOD RECOVERY. ACCORDING TO PATIENT, RESTRICTIONS WERE FOLLOWED. ON (B)(6) 2021, A FRACTURE IN NEON WAS DETECTED IN MR. PATIENT IS WELL, WAITING TO KNOW THE NEXT STEPS. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12984392 ↗