Simplify 2-4EV-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843285101969), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (P200022); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Break; Crack; Migration; Break; Crack; Migration

  IT WAS REPORTED THAT, APPROXIMATELY 42 MONTHS AFTER RECEIVING A CERVICAL TOTAL DISC REPLACEMENT AT C5/6, THE PATIENT WAS SEEN FOR A FOLLOW-UP AND REPORTED HAVING RADIATING UPPER EXTREMITY PAIN. IMAGING WAS PERFORMED AND REVIEWED BY THE SURGEON, WHO NOTED THE IMPLANT EXHIBITED UNSPECIFIED DAMAGE AND SEEMED TO EXHIBIT SUBSIDENCE AT THE INFERIOR C5 ENDPLATE WITH A LOSS OF INTERVERTEBRAL HEIGHT AT C5/6. A REVISION PROCEDURE IS PLANNED BUT HAS NOT YET OCCURRED. THERE WAS NO REPORT FROM THE PATIENT OF ANY TRAUMATIC EVENTS OCCURRING AND IT IS NOT BELIEVED THE PATIENT EXHIBITS BONE QUALITY ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis; Pain; Radiolucent Lines; Unspecified Infection

  MAUDE report 18832886 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200022. One submission often covers many models, so check the product and lot details in each record.

• Z-1453-2022 · Jun 20, 2022 · Open, Classified
  Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht