Simplify 3-5-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843285102119), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA SIMPLIFY 2-LEVEL CLINICAL REVIEW THAT ON AN UNKNOWN DATE A PATIENT UNDERWENT A SIMPLIFY DISC REPLACEMENT. AROUND 48 MONTHS POST-OP ON (B)(6) 2022 IT WAS REPORTED THERE WAS HETEROTOPIC OSSIFICATION AT THE INDEX LEVELS OF C5/6. NO TREATMENT WAS GIVEN AND THERE IS NO PLAN TO REMOVE OR REVISE THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification

  MAUDE report 15204209 ↗

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