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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843285100023), received between Apr 14, 2023 and Apr 13, 2026 — classified as 1 injury, 2 malfunctions.

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

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.

• MalfunctionApr 13, 2026Implant subsidence

  REVISION OF 1 LEVEL FUSION AND 1 LEVEL CTDR TO 1 LEVEL FUSION. FUSION C5-6 CTDR C6-7. REMOVAL OF SIMPLIFY DISC DUE TO COLLAPSED VERTEBRAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866063 ↗
• InjuryApr 22, 2024Off-Label Use; Off-Label Use

  IN (B)(6) 2020 A PATIENT UNDERWENT A C4-5 CERVICAL TOTAL DISC REPLACEMENT (CTDR) FROM ANOTHER MANUFACTURER. IN (B)(6) 2023 A REVISION TOOK PLACE WHERE THE UNKNOWN C4-5 CTDR WAS REVISED TO A SIMPLIFY DISC AND AN ANTERIOR CERVICAL DISCECTOMY FUSION WAS COMPLETED AT C5-C6. ON (B)(6) 2023 THE PATIENT COMPLAINED OF NECK PAIN AND RADIOGRAPHS IDENTIFIED PERI-IMPLANT LUCENCY AROUND AND A REVISION IS BEING PLANNED.

  Patient problems: Extraskeletal ossification; Neck Pain; Osteolysis

  MAUDE report 19159397 ↗
• MalfunctionApr 14, 2023Migration; Migration

  ON (B)(6) 2022 , A CT SCAN WAS DONE DUE TO NO RELIEF FROM CONTINUED NECK AND SHOULDER PAIN. NOTING THE DISC SLIPPED OUT OF PLACE AGAIN AT C6/7 AS WELL AS THE DISC AT C5/6 AND WILL HAVE TO HAVE SURGERY AGAIN. ON (B)(6) 2022, A REVISION TOOK PLACE REMOVING BOTH MIGRATED DISCS AT C5/6 AND C6/7 AND REPLACED WITH ALLOGRAFT FOR FUSION. (2 OF 2 (B)(4)).

  Patient problems: Limb Pain; Neck Pain

  MAUDE report 16747776 ↗