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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843285100061), received between Mar 22, 2024 and Aug 15, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE A PATIENT UNDERWENT CERVICAL TOTAL DISC REPLACEMENT (CTDR) PROCEDURE AT C6/7 DUE TO NECK PAIN AND CERVICAL STENOSIS. ON (B)(6) 2024 THE PATIENT REPORTED NECK PAIN AND RETURN OF PRE-OPERATIVE SYMPTOMS AND A REVISION WAS PERFORMED THE CTDR AT C6/7 WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A STANDALONE FUSION DEVICE.

  Patient problems: Pain

  MAUDE report 19996457 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2023 A PATIENT UNDERWENT TWO CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C5-6 AND C6-7 WITHOUT A REPORTED ISSUE. IN (B)(6) 2024 THE PATIENT COMPLAINED OF NECK PAIN AND RADIOGRAPHS IDENTIFIED PERI-IMPLANT LUCENCY, CYSTIC ENDPLATE CHANGES AT BOTH LEVELS AND A REVISION IS BEING PLANNED.

  Patient problems: Extraskeletal ossification; Neck Pain; Osteolysis; Unspecified Infection

  MAUDE report 19149523 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL CERVICAL TOTAL DISC REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE ONE DISC PROSTHESIS. THE REASON FOR REMOVAL OR THE SCOPE OF THE REVISION PROCEDURE WAS NOT PROVIDED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18960667 ↗