Simplify® Cervical Artificial Disc (REF MD-4)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00843285100054), received between Jul 14, 2022 and Apr 30, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SIMPLIFY DISC EXPLANT OCCURRED DUE TO OSTEOLYSIS AND RETURN OF ARM AND NECK PAIN. EXPLANT AND FUSION AT 5-6, 6-7 OCCURRED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 25050236 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C5/6 WITH NO REPORTED ISSUES. ON (B)(6), 2023 THE PATIENT REPORTEDLY RECEIVED A TWO LEVEL CTDR AT C4/5 AND C6/7 WITH NO REPORTED PROBLEMS BUT CONSIDERED OFF LABEL USAGE. ON (B)(6) 2025 FOLLOW UP THE SURGEON NOTED RECURRENT SYMPTOMS AND POSSIBLE OSTEOLYSIS BUT NO REVISION PLANNED AT THIS TIME.

  Patient problems: Extraskeletal ossification; Inadequate Pain Relief; Osteolysis

  MAUDE report 21636396 ↗
• InjurySep 18, 2023Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL TOTAL DISC REPLACEMENT PROCEDURE AT C4/5 AND C5/6. SUBSEQUENTLY, DURING THE 60-MONTH VISIT WITH THE SURGEON, CT AND MRI IMAGING WAS OBTAINED AND OSTEOLYSIS WAS IDENTIFIED AT THE THREE (3) VERTEBRAL BODIES ADJACENT TO THE IMPLANTS. APPROXIMATELY FOUR (4) MONTHS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE TWO (2) DISC IMPLANTS AND PERFORM A CORPECTOMY OF THE C5 VERTEBRAL BODY. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Osteolysis; Pain

  MAUDE report 17769214 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON A STUDY THAT A PATIENT UNDERWENT A TOTAL DISK REPLACEMENT AT C5/6 ON (B)(6) 2017. THE PATIENT REPORTED NEW ONSET OF RADICULOPATHY SYMPTOMS THAT HAVE INCREASED OVER THE PAST YEAR. A TENTATIVE FOLLOW-UP SURGERY IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain

  MAUDE report 17191099 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW AND UPDATED INFORMATION LIST ON SECTION H10.

  Patient problems: Pain

  MAUDE report 16358524 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH SIMPLIFY DISCS AT C4/5 AND C5/6 APPROXIMATELY 3 YEARS PRIOR TO EXPLANTATION ON (B)(6) 2022, WHERE BOTH DISCS WERE REMOVED DUE TO UNSUCCESSFUL PAIN RELIEF AS A RESULT OF CONTINUED MYELOPATHY. THERE WERE NO DEVICE ISSUES FOUND DURING THE REMOVAL (HOWEVER, THE INFERIOR PLATE AT C5/6 WAS DAMAGED DURING REMOVAL) AND THERE WERE NO FURTHER PATIENT COMPLICATIONS OR ADVERSE CONDITIONS NOTED. AS PART OF THE PROCEDURE, THE PATIENT WAS REVISED FOR FUSION FROM C4 TO C6. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15936456 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 4.5 MONTHS AFTER IMPLANTATION AT LEVEL C5/6, A SIMPLIFY DISC WAS REMOVED AFTER THE PATIENT DID NOT EXPERIENCE RELIEF OF UNIDENTIFIED SYMPTOMS RELATED TO DEGENERATIVE DISC DISEASE. NO DEVICE PROBLEM OR DAMAGE WAS NOTED UPON REMOVAL. THERE WERE NO REPORTED COMPLICATIONS DURING THE REMOVAL SURGERY AND NO FURTHER ADVERSE PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 15019551 ↗

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