Simplify 1-4EV-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843285101877), received between Jun 11, 2024 and Jul 13, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Neck Pain

  MAUDE report 25801070 ↗
• InjuryJun 20, 2024Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2018 A PATIENT UNDERWENT CERVICAL TOTAL DISC REPLACEMENT PROCEDURES AT C4-5 AND C5-6 WITHOUT A REPORTED ISSUE. ON (B)(6) 2024 DURING 6 YEAR FOLLOW UP VISIT C/O RIGHT SIDED NECK AND ARM PAIN FOR APPROXIMATELY 8 MONTH DURATION. CT AND MRI ORDERED AT THAT TIME. ON (B)(6) 2024 CT IMAGES RECEIVED AND REVIEWED NOTED OSTEOLYSIS WAS CONFIRMED AND A REMOVAL REVISION IS SET TO OCCUR FOR BOTH. (2 OF 2) C5/6.

  Patient problems: Osteolysis

  MAUDE report 19577309 ↗
• InjuryJun 20, 2024Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6), 2018 A PATIENT UNDERWENT CERVICAL TOTAL DISC REPLACEMENT PROCEDURES AT C4-5 AND C5-6 WITHOUT A REPORTED ISSUE. ON (B)(6), 2024 DURING 6 YEAR FOLLOW UP VISIT C/O RIGHT SIDED NECK AND ARM PAIN FOR APPROXIMATELY 8 MONTH DURATION. CT AND MRI ORDERED AT THAT TIME. ON (B)(6), 2024 CT IMAGES RECEIVED AND REVIEWED NOTED OSTEOLYSIS WAS CONFIRMED AND A REMOVAL REVISION IS SET TO OCCUR FOR BOTH. (1 OF 2) C4/5.

  Patient problems: Osteolysis

  MAUDE report 19576906 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A PATIENT RECEIVED A TWO LEVEL CERVICAL TOTAL DISC REPLACEMENT AT C4/5 AND C5/6 CURRENT SYMPTOMS ARE MILD NECK/ARM PAIN (3/10) WHICH HAS BEEN ONGOING FOR ABOUT 8 MONTHS. X-RAYS TAKEN AT THE 72-MONTH VISIT WERE CONCERNING SO THE INVESTIGATOR ORDERED A CT. THE CT WAS RECENTLY OBTAINED AND SHOWS SEVERE OSTEOLYSIS AT BOTH INDEX LEVELS. THE SURGEON IS STILL DEVELOPING A SURGICAL PLAN FOR EXPLANTING BOTH DEVICES. THE SURGERY IS NOT YET SCHEDULED. (1 OF 2) (B)(4).

  Patient problems: Limb Pain; Neck Pain; Osteolysis

  MAUDE report 19515848 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A PATIENT RECEIVED A TWO LEVEL CERVICAL TOTAL DISC REPLACEMENT AT C4/5 AND C5/6 CURRENT SYMPTOMS ARE MILD NECK/ARM PAIN (3/10) WHICH HAS BEEN ONGOING FOR ABOUT 8 MONTHS. X-RAYS TAKEN AT THE 72-MONTH VISIT WERE CONCERNING SO THE INVESTIGATOR ORDERED A CT. THE CT WAS RECENTLY OBTAINED AND SHOWS SEVERE OSTEOLYSIS AT BOTH INDEX LEVELS. THE SURGEON IS STILL DEVELOPING A SURGICAL PLAN FOR EXPLANTING BOTH DEVICES. THE SURGERY IS NOT YET SCHEDULED. (2 OF 2) (B)(4).

  Patient problems: Limb Pain; Neck Pain; Osteolysis

  MAUDE report 19515771 ↗

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