Simplify 2-4-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843285101952), received between Nov 29, 2021 and Jan 26, 2022 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 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 WAS EXPERIENCING HETEROTOPIC OSSIFICATION AT C5/6 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 13362012 ↗
• InjuryJan 26, 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 WAS EXPERIENCING HETEROTOPIC OSSIFICATION AT THE INDEX LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 13361945 ↗
• InjuryJan 26, 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 WAS EXPERIENCING HETEROTOPIC OSSIFICATION AT THE INDEX LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 13361941 ↗
• InjuryJan 26, 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 WAS EXPERIENCING HETEROTOPIC OSSIFICATION AT C5/6 48 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 13361827 ↗
• 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT GIVEN FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12902555 ↗
• 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT GIVEN FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12902236 ↗
• 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT GIVEN FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12902001 ↗
• 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12901716 ↗
• 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 C5/6 LEVEL 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE IS NO REPORTED PLAN TO REMOVE OR REVISE THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 12901448 ↗
• InjuryNov 29, 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12888703 ↗
• InjuryNov 29, 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 LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12888700 ↗
• InjuryNov 29, 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 LEVELS 48 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Extraskeletal ossification

  MAUDE report 12888668 ↗
• InjuryNov 29, 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 LEVELS 48 MONTHS AFTER THEIR INDEX PROCEDURE AT C5/6 AND C6/7 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2..

  Patient problems: Extraskeletal ossification

  MAUDE report 12888666 ↗

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