Simplify 5708914P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00195377105400), received between Jan 4, 2024 and May 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SIMPLIFY IMPLANT WAS EXPLANTED FROM THE PATIENT DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 25258020 ↗
• MalfunctionMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SIMPLIFY DISC EXPLANT WAS PLANNED FOR (B)(6) 2026 DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 25164319 ↗
• MalfunctionMay 6, 2026Adverse Event Without Identified Device or Use Problem

  UNRESOLVED NECK PAIN. INITIAL SURGERY: 2025 WITH DR. (B)(6) AT (B)(6). REVISION: (B)(6) 2026 WITH DR (B)(6) AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101017 ↗
• MalfunctionAug 25, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A SIMPLIFY CAGE MIGRATED POST OPERATIVELY.

  Patient problems: Failure of Implant

  MAUDE report 22883179 ↗
• MalfunctionMar 18, 2025Implant subsidence; Implant subsidence

  ON (B)(6) 2024 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR). DURING THE 3 MONTH FOLLOW UP THE SURGEON NOTED POST OPERATIVE SUBSIDENCE AT THE INDEX LEVEL. NO REVISION IS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638881 ↗
• MalfunctionJan 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL CERVICAL TOTAL DISC REPLACEMENT. SUBSEQUENTLY, POST-OPERATIVE IMAGING OBTAINED ON AN UNKNOWN DATE SHOWED THE SUPERIOR PLATE OF THE SIMPLIFY DISC HAD FRACTURED. IT WAS NOTED THAT THE PATIENT DID NOT PRESENT WITH ANY ISSUES AT THE TIME OF THE REPORT, APPROXIMATELY FIVE (5) MONTHS POST-OP. IT IS UNKNOWN IF THERE ARE PLANS TO REVISE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446782 ↗

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