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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843285100115), received between Mar 22, 2023 and Apr 8, 2026 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Implant subsidence

  SIMPLIFY IMPLANT SUBSIDED FROM OSTEOLYSIS. EXPLANT TOOK PLACE ON (B)(6) 2026.

  Patient problems: Osteolysis

  MAUDE report 24815431 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 THE SURGEON REMOVED THE SIMPLIFY DEVICE FROM C6/7 QUERYING OSTEOLYSIS. UPON LOOKING AT THE DEVICE PATCHES OF THE TI COATING FROM THE ENDPLATES HAD DELAMINATED FROM THE PEEK BODY. WOUND SWABS WERE TAKEN AND SENT TO PATHOLOGY, AN ACDF WAS PERFORMED AND THE EXPLANTED DEVICE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Osteolysis

  MAUDE report 20292943 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A TOTAL DISC REPLACEMENT WAS CONDUCTED AT C6/7. IN (B)(6) 2023 AN EXPLANT SURGERY WAS CONDUCTED FOR UNSPECIFIED REASONS.

  Patient problems: Bacterial Infection; Cyst(s); Radiolucent Lines; Stenosis

  MAUDE report 18030442 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A PATIENT UNDERWENT A 1-LEVEL SIMPLIFY PROCEDURE AT C6/7. ON (B)(6) 2023 A REMOVAL SURGERY TOOK PLACE FOR AN UNREPORTED REASON NOTING ONLY FAILED PATIENT SELECTION AND OSTEOPOROSIS. NO ADDITIONAL INFORMATION COULD BE ACQUIRED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 16593589 ↗