Simplify 2-5-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843285101976), received between Mar 1, 2022 and Jun 26, 2023 — classified as 2 injuries, 1 malfunction.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE-LEVEL CERVICAL TOTAL DISC REPLACEMENT PROCEDURE USING THE SIMPLIFY DISC AT C5/6 AS A PART OF A CLINICAL STUDY AND TO ADDRESS LEFT C5/6 DISC HERNIATION. APPROXIMATELY SEVEN (7) YEARS LATER, A REVISION SURGERY WAS PERFORMED WHERE THE SIMPLIFY DISC WAS REMOVED AND A THREE-LEVEL FUSION PROCEDURE WAS PERFORMED FROM C4 TO C7. THE SURGEON CITED THE BREAKDOWN OF THE CERVICAL LEVELS SUPERIOR AND INFERIOR TO THE SIMPLIFY DISC AS THE REASON FOR THE REMOVAL OF THE DISC AND THE MOVE TO A FUSION PROCEDURE; SPECIFICALLY, TO ADDRESS SEVERE NECK AND ARM PAIN, DECREASED UPPER EXTREMITY REFLEXES AND SENSATION, SEVERE STENOSIS, CERVICAL MYELOPATHY, AND LOSS OF DISC SPACE HEIGHT AT C4/5, AND A COLLAPSING DISC AT C6/7 WITH FORAMINAL STENOSIS AT SEVERE LEFT C6/7. THE REVISION PROCEDURE WAS REPORTEDLY SUCCESSFUL WITH NO PROBLEMS ENCOUNTERED AND THERE WERE NO NOTED ISSUES WITH THE SIMPLIFY DISC ITSELF. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Intervertebral Disc Compression or Protrusion; Limb Pain; Neck Pain; Pain; Stenosis

  MAUDE report 17205897 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA CLINICAL STUDY THAT A PATIENT UNDERWENT A CERVICAL PROCEDURE ON (B)(6) 2018 WITH A SIMPLIFY DISC REPLACEMENT. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HETEROTOPIC OSSIFICATION AT THE INDEX LEVEL OF C5/6. NO TREATMENT HAS BEEN GIVEN AND THERE IS NO PLAN TO REMOVE OR REVISE THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 15033015 ↗
• MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA CLINICAL STUDY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HETEROTOPIC OSSIFICATION AT THE C6/7 INDEX LEVEL OF A SIMPLIFY IMPLANT. NO CURRENT TREATMENT IS BEING PERFORMED FOR THE HETEROTOPIC OSSIFICATION AND THERE IS NO REPORTED PLAN TO REMOVE OR REVISE THE SIMPLIFY IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 13643000 ↗

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 5, 5