Simplify 2-5L-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843285101990), received between Jan 20, 2022 and Jan 23, 2023 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A SIMPLIFY 2 LEVEL STUDY THAT ON (B)(6) 2019 A PATIENT UNDERWENT A SPINAL PROCEDURE AT C5/C7. ON (B)(6) 2022 ANOTHER SURGERY WAS CONDUCTED WHERE ANOTHER MANUFACTURER'S POSTERIOR FIXATION WAS ADDED AT C3 TO C7 DUE TO CERVICAL RADICULOPATHY AND MYELOPATHY AND THE SIMPLIFY DISCS WERE LEFT IN PLACE.

  Patient problems: Pain

  MAUDE report 16230167 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW AND UPDATED INFORMATION LISTED ON SECTION H10.

  Patient problems: Extraskeletal ossification; Stenosis

  MAUDE report 16230146 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA CLINICAL STUDY, IT AS REPORTED THAT AT 48 MONTHS AFTER THE INDEX PROCEDURE AT C5/6, A PATIENT UNDERWENT A HEMILAMINOTOMY, PARTIAL FACETECTOMY, FORAMINOTOMY, AND NERVE ROOT DECOMPRESSION AT C5/6 ON THE POSTERIOR CERVICAL LEFT, AND AT C6/7 ON THE POSTERIOR CERVICAL RIGHT. ALL PATIENT ISSUES WERE REPORTED TO BE RESOLVED AFTER THE PROCEDURE. NO ADDITIONAL PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information; Neck Pain

  MAUDE report 14137631 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA CLINICAL STUDY THAT APPROXIMATELY 60 MONTHS AFTER AN INDEX PROCEDURE AT C3/4, THE PATIENT EXPERIENCED STENOSIS AT LEVELS C3 TO T2 WITH MYELOPATHY, LEFT AND RIGHT ARM PAIN, NUMBNESS, AND WEAKNESS, AXIAL NECK PAIN, AND BILATERAL FORAMINAL STENOSIS AT LEVELS C5 TO T1. TREATMENT INCLUDED POSTERIOR CERVICAL DECOMPRESSION AND FIXATION FROM C3 TO T2. THE PATIENT HAS REPORTEDLY RECOVERED.

  Patient problems: Muscle Weakness/Atrophy; Neck Pain; Numbness; Pain; Stenosis

  MAUDE report 13773365 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA CLINICAL STUDY, IT WAS REPORTED THAT AT THE INDEX LEVEL OF C5/6, THE PATIENT DEVELOPED UNCOVERTEBRAL HYPERTROPHY WITH RIGHT AND LEFT SIDED NEURAL FORAMINAL STENOSIS. PATIENT HAS BEEN CONTINUING THERAPY WITH MEDICATION OF ACETAMINOPHEN, CYCLOBENZAPRINE, AND DULOXETINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 13311446 ↗

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