Simplify® Cervical Artificial Disc (REF MD-5L)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843285100078), received between Dec 7, 2022 and Oct 30, 2024 — classified as 3 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 20, 2022Open, Classified

   Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.

   Z-1453-2022 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APPROXIMATELY ON (B)(6) 2024, A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) PROCEDURE AT C4/5. ON (B)(6) 2024, A REVISION PROCEDURE WAS COMPLETED DURING AND DURING THE EXPLANT OF THE CTDR THERE WERE CLEAR SIGNS OF METALLOSIS WHICH CAUSED A CYST OF FLUID BUILD UP IN THE PATIENT VERTEBRAL BODY CAUSING SEVERE PAIN AND RESULTED IN A FUSION PROCEDURE.

  Patient problems: Cyst(s); Metal Related Pathology; Neck Pain

  MAUDE report 20571556 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW AND UPDATED INFORMATION LISTED ON H10.

  Patient problems: Pain

  MAUDE report 16358540 ↗
• 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, 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 IMPLANT 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 15934982 ↗