Simplify 1-5S-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843285101914), received between Nov 15, 2021 and Nov 30, 2021 — classified as 2 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 2 most recent of 2 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 HETEROTOPIC OSSIFICATION AT THE INDEX LEVEL APPROXIMATELY 48 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 WITH A SIMPLIFY IMPLANT. THERE HAS BEEN NO REPORTED TREATMENT GIVEN FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 12904818 ↗
• InjuryNov 15, 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 EXPERIENCED HETEROTOPIC OSSIFICATION AT THE C5/6 INDEX LEVEL OF A SIMPLIFY IMPLANT. IT WAS ALSO REPORTED THAT IN RELATION TO THE HETEROTOPIC OSSIFICATION, THE PATIENT EXPERIENCED A HERNIATED DISC AT THE C6/7 LEVEL WHICH REQUIRED A DISCECTOMY/ DISC ARTHROPLASTY ON (B)(6) 2020. THE PATIENT WAS FURTHER TREATED WITH PAIN MEDICATION. THERE IS NO REPORTED PLAN TO REMOVE OR REVISE THE SIMPLIFY IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Intervertebral Disc Compression or Protrusion

  MAUDE report 12817708 ↗

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