Simplify 3-6L-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843285102171), received between Nov 30, 2021 and Nov 30, 2021 — classified as 1 injury.

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.

• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA CLINICAL STUDY, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO SEVERE SPINAL STENOSIS AT THE INDEX LEVEL OF C6/7 WITH MARKED RIGHT AND MODERATE LEFT FORAMINAL STENOSIS C6/7. THIS WAS FOUND APPROXIMATELY 60 MONTHS AFTER THE INDEX PROCEDURE AND REQUIRED TREATMENT WITH NARCOTICS. THERE IS CURRENTLY NO PLAN TO REMOVE OR REVISE THE IMPLANT AND TREATMENT IS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Stenosis

  MAUDE report 12905319 ↗

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