Simplify 3-5L-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843285102133), received between Aug 13, 2021 and Jul 16, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Implant subsidence” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Implant subsidence

  Patient problems: Osteolysis

  MAUDE report 25846392 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE IS A PLANNED PROCEDURE TO EXPLANT A SIMPLIFY DISC AT C5/6 (INDEX AT C4/5 AND C5/6) TO ADDRESS STENOSIS AT C6/7 AND C6/7 RADICULOPATHY WITH PROGRESSIVE NEUROLOGICAL DEFICIT IN THE LEFT UPPER EXTREMITY. THE SURGEON ATTRIBUTES PATIENT SYMPTOMS TO OSTEOPHYTES AT C5/6 WITH SEVERE FORAMINAL STENOSIS ON THE LEFT SIDE COMPRESSING THE C6 NERVE ROOT AND SPONDYLOSIS AT C6/7 WITH MODERATE-TO-SEVERE FORAMINAL STENOSIS COMPRESSING THE C7 NERVE ROOT. THE PROCEDURE IS SCHEDULED FOR 14 DEC 2021 WITH A PLAN TO REMOVE THE SIMPLIFY DISC AT C5/6 AND PERFORM A PLATE/FUSION AT LEVELS C5-7. NO ISSUES WERE NOTED FOR THE IMPLANT AT C4/5. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Extraskeletal ossification; Muscle Weakness/Atrophy; Pain; Stenosis

  MAUDE report 12939443 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN IDE SUBJECT WAS IMPLANTED WITH A SIMPLIFY DISC AT LEVEL C6/7. APPROXIMATELY 64 MONTHS AFTER IMPLANTATION, THE DEVICE WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING RECURRENT STENOSIS WITH FAILED INJECTION RELIEF, AND SEVERE RADICULOPATHY. DURING THE REMOVAL PROCEDURE, NO SUBSIDENCE OR DEVICE DAMAGE OR MALFUNCTION WAS FOUND. THIS IS A SUPPLEMENTAL REPORT FOR A PREVIOUS ADVERSE REPORT (3012070713-2021-00004).

  Patient problems: Pain; Stenosis

  MAUDE report 12320964 ↗

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