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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843285100108), received between Oct 19, 2022 and Jul 14, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Implant subsidence

  Patient problems: Failure of Implant

  MAUDE report 25813258 ↗
• InjuryMar 12, 2025Noise, Audible; Noise, Audible

  ON (B)(6) 2025 A PATIENT UNDERWENT AN CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C6/7 DUE TO STENOSIS. AFTER THE PROCEDURE, THE PATIENT REPORTED THAT THE DISC MADE A NOISE WHEN MOVING THEIR HEAD/SPINE. ON (B)(6) 2025 A REVISION PROCEDURE TOOK PLACE WHEREIN THE ARTIFICIAL DISC AT C6/7 WAS REMOVED AND REPLACED WITH A NEW ONE. AFTER RE-IMPLANTATION OF THE REPLACEMENT PROSTHESIS NO NOISE OR CERVICAL DISCOMFORT WAS OBSERVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21585645 ↗
• MalfunctionFeb 10, 2025Migration; Migration

  NEW OR UPDATED INFORMATION LISTED ON SECTION H10.

  Patient problems: Failure of Implant

  MAUDE report 21346185 ↗
• MalfunctionJul 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  ON (B)(6) 2024 AND PATIENT UNDERWENT CERVICAL TOTAL DISC REPLACEMENT AT C5/6 AND C6/7 TO REPORTEDLY TREAT ADJACENT SEGMENT DISORDER, NECK PAIN AND ARM PAIN. ON (B)(6) 2024 DURING A FOLLOW UP THE PATIENT REPORTED BEING MISERABLE WITH NECK PAIN, THROWING UP FROM PAIN AND RADIOGRAPHS SUGGEST SUBSIDENCE AND A REVISION IS BEING PLANNED. ON (B)(6) 2024 A REVISION TOOK PLACE ON BOTH DISCS WERE REMOVED AND THE DISC ENDPLATE AT C6/7 WAS FOUND LOOSE, REMOVAL WAS COMPLETED WITHOUT A REPORTED PROBLEM. (2 OF 2) (B)(4) ((B)(4)).

  Patient problems: Pain; Vomiting

  MAUDE report 19794770 ↗
• MalfunctionJul 15, 2024Migration; Migration

  ON 05/28/2024 AND PATIENT UNDERWENT CERVICAL TOTAL DISC REPLACEMENT AT C5/6 AND C6/7 TO REPORTEDLY TREAT ADJACENT SEGMENT DISORDER TO A PREVIOUS ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3/5 DUE TO NECK AND ARM PAIN. ON (B)(6) 2024 DURING A FOLLOW UP THE PATIENT REPORTED BEING MISERABLE WITH NECK PAIN, THROWING UP FROM PAIN AND RADIOGRAPHS SUGGEST SUBSIDENCE AND A REVISION IS BEING PLANNED. ON (B)(6) 2024 A REVISION TOOK PLACE WHERE THE SURGEON ELECTED TO REMOVE BOTH DISCS AND THE DISC ENDPLATE AT C6/7 WAS FOUND LOOSE, REMOVAL WAS COMPLETED WITHOUT A REPORTED PROBLEM. (1 OF 2) SM032A C5/6 (200075804).

  Patient problems: Pain

  MAUDE report 19745592 ↗
• InjuryApr 22, 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. (2 OF 2).

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

  MAUDE report 19152238 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Cyst(s); Extraskeletal ossification; Neck Pain; Osteolysis; Radiolucent Lines

  MAUDE report 19146898 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PATIENT UNDERWENT A TOTAL DISK REPLACEMENT AT C6/7. AT THE 3 MONTH FOLLOW UP AROUND ON (B)(6) 2024, THE PATIENT REPORTED NECK PAIN AND HEADACHES. A CT REVEALED LATERAL BONY FUSION AT THE INDEX LEVEL. RADIOGRAPHS REVEALED HETEROTOPIC OSSIFICATION.

  Patient problems: Extraskeletal ossification; Headache; Neck Pain

  MAUDE report 18882091 ↗
• InjuryNov 10, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Migration; Fracture; Adverse Event Without Identified Device or Use Problem; Migration

  DEVICE RETURNED NEW INFORMATION LISTED ON H10.

  Patient problems: Bacterial Infection; Osteolysis; Stenosis

  MAUDE report 18115034 ↗
• MalfunctionMar 27, 2023Flaked; Flaked

  ON (B)(6), 2023 DURING A SIMPLIFY DISC REPLACEMENT PROCEDURE PART OF THE TITANIUM COATING ON THE ENDPLATE OF THE IMPLANT CHIPPED OFF DURING IMPLANTATION WHERE A TAMP WAS UTILIZED. SOME COATING FLAKED OFF MAINLY FROM THE SUPERIOR END PLATE AND A LITTLE FROM THE INFERIOR. THE SURGEON REMOVED THE CHIPS HE SAW, BUT IT CANNOT BE CONFIRMED THAT 100% OF THE FLAKES WERE REMOVED. THE DEVICE WAS LEFT IN-SITU. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623171 ↗
• InjuryDec 22, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL CERVICAL DISC REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTIES WITH TAMPING THE DISC ASSEMBLY INTO THE DISC SPACE. THE SURGEON WAS CONCERNED THAT THE DISTANCE BETWEEN THE ENDPLATES WAS LARGER THAN THE FACE OF THE TAMP, RESULTING IN FORCE APPLIED TO ONLY ONE ENDPLATE, AND CAUSING THE IMPLANT TO DISASSEMBLE. THE IMPLANT WAS REASSEMBLED AND IMPLANTATION ATTEMPTED AGAIN; HOWEVER, THIS WAS UNSUCCESSFUL. THE SURGEON OPTED TO DISCONTINUE THE DISC REPLACEMENT PROCEDURE AND PERFORM AN ANTERIOR FUSION PROCEDURE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040629 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA MED WATCH MW5111949 AND PATIENT CONTACT IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TWO LEVEL TOTAL DISC REPLACEMENT PROCEDURE AT (C5-6, C6-7)WITH NO REPORTED ISSUES. (B)(6) 2022 THE PATIENTS PAIN RETURNED (ACHING NECK PAIN) SURGEONS EVALUATION IDENTIFIED A P-ACNE INFECTION AND HE SUGGESTS POSSIBLE OSTEOLYSIS. ON (B)(6) 2022 A REVISION TOOK PLACE WHERE A CORPECTOMY/FUSION WAS COMPLETED AND CURRENTLY BEING TREATED WITH 6 WEEK COARSE OF WITH IV ANTIBIOTICS.

  Patient problems: Bacterial Infection; Osteolysis; Vertebral Fracture

  MAUDE report 15632489 ↗