Simplify® Cervical Artificial Disc (REF SM-4)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843285100009), received between Feb 21, 2022 and Apr 14, 2026 — classified as 6 injuries, 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (P200022); they may or may not involve this specific model.

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.

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.

• MalfunctionApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REMOVAL OF C3-C4 AND C4-C5 SIMPLIFY DISCS OCCURRED ON (B)(6) 2026. ORIGINAL DATE OF IMPLANTATION (B)(6) 2024. REVISION TO C4 CORPECTOMY AND FUSION. IT IS REPORTED THAT THE REASON FOR REMOVAL IS OSTEOLYSIS. C4-5 END PLATE LOOSE UPON REMOVAL. SPECIFICALLY, C-5 ENDPLATE, C4 ENDPLATE NOT LOOSE. C3-C4 ENDPLATES ARE NOT LOOSE AND SEEM WELL BONDED.

  Patient problems: Osteolysis

  MAUDE report 24876863 ↗
• MalfunctionAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SIMPLIFY IMPLANT HAD OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 22902392 ↗
• MalfunctionAug 25, 2025Implant subsidence; Implant subsidence

  SUBSIDENCE AT 4 WEEK FOLLOW UP. NOTED NO REPLACEMENT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883657 ↗
• InjuryApr 30, 2025Noise, Audible; Noise, Audible

  ON (B)(6) 2023 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C4/5 AND C5/6 AS A RESULT OF TWO HERNIATED DISCS. POSTOPERATIVELY SHE HAS RECEIVED NO PAIN RELIEF AND IS EXPERIENCING NEW OCCIPITAL PAIN, ADDITIONALLY SHE HAS BEEN EXPERIENCING SQUEAKING AND CLICKING SOUNDS DURING ARTICULATION FOLLOWED BY PAIN. THE PAIN HAS STEADILY INCREASED AND AS A RESULT SHE IS UNABLE TO PERFORM WORK AND RECREATION ACTIVITIES. SURGEONS COMMENTED HIS RADIOGRAPHS SUGGESTED POSSIBLE HETEROTOPIC OSSIFICATION AND POSSIBLE NON-FUSION OF DISC END PLATES ALL THOUGH NO RADIOGRAPHS OR IMAGES HAVE BEEN PROVIDED AT THIS TIME NOR HAS A REVISION BEEN COMPLETED OR SCHEDULED.

  Patient problems: Extraskeletal ossification; Neck Pain

  MAUDE report 21937833 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT WAS IDENTIFIED DURING REVIEW OF THE SM2 SIMPLIFY DISC 2 LEVEL STUDY REPORT THAT NOTED ON (B)(6) 2018, A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT AT C6/7. ON (B)(6) 2024, THE PATIENT WAS PRESENTED AT THE 72 WEEK FOLLOW UP WITH SPONTANEOUS FUSION AT THE C6/7 INDEX LEVEL AND NOTED AS HETEROTOPIC OSSIFICATION, BUT NO TREATMENT HAS BEEN PROVIDED AS IT WAS CONSIDERED A PERMANENT AUTO-FUSION AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Extraskeletal ossification

  MAUDE report 20913793 ↗
• InjurySep 18, 2023Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL TOTAL DISC REPLACEMENT PROCEDURE AT C4/5 AND C5/6. SUBSEQUENTLY, DURING THE 60-MONTH VISIT WITH THE SURGEON, CT AND MRI IMAGING WAS OBTAINED AND OSTEOLYSIS WAS IDENTIFIED AT THE THREE (3) VERTEBRAL BODIES ADJACENT TO THE IMPLANTS. APPROXIMATELY FOUR (4) MONTHS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE TWO (2) DISC IMPLANTS AND PERFORM A CORPECTOMY OF THE C5 VERTEBRAL BODY. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Osteolysis; Pain

  MAUDE report 17769355 ↗
• InjurySep 11, 2023Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  ON (B)(6) 2023 A PATIENT UNDERWENT A TOTAL DISC REPLACEMENT PROCEDURE AT C5/6 AND C6/7. ON AN UNKNOWN DATE THE PATIENT REPORTEDLY SNEEZED AND FELT PAIN, THE PATIENTS BONE QUALITY WAS REPORTED AS GOOD. DURING SURGEON EXAMINATION HE IDENTIFIED THE DISC MIGRATED AND THE PATIENTS INFERIOR END PLATE FRACTURED ON THE RT SIDE AND DISC SPACE COLLAPSED. ON (B)(6) 2023 A REVISION TOOK PLACE WHERE THE DISC AT C6/7 WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURES DEVICE WITH POSTERIOR FUSION FROM C5-C7.

  Patient problems: Bone Fracture(s); Neck Pain; Osteolysis; Vertebral Fracture

  MAUDE report 17725730 ↗
• InjurySep 6, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE-LEVEL CERVICAL DISC REPLACEMENT PROCEDURE AT C5/6. SUBSEQUENTLY, THE PATIENT NOTED CONTINUED PAIN IN THE AREA FOR SEVERAL MONTHS AND MULTIPLE EVALUATIONS OF THE IMPLANT BY THE INITIAL SURGEON NOTED NO ISSUES WITH THE APPEARANCE OR POSITIONING. ON AN UNKNOWN DATE, THE PATIENT REPORTED INCREASING PAIN AND A SECOND OPINION WAS SOUGHT FROM AN UNKNOWN NEUROPHYSIOLOGIST. THE NEUROPHYSIOLOGIST OBTAINED IMAGES AND NOTED OSTEOMYELITIS AROUND THE PROSTHESIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE DISC REPLACEMENT AND PERFORM A FUSION APPROXIMATELY TEN (10) MONTHS AFTER THE INITIAL PROCEDURE. EROSION OF THE C5 AND C6 VERTEBRAL BODIES DUE TO THE INFECTION WAS NOTED ALONG WITH A SIGNIFICANT AMOUNT OF SCAR TISSUE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT OF THE INFECTION. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Erosion; Osteomyelitis; Pain

  MAUDE report 17693008 ↗
• MalfunctionMay 3, 2023Migration; Migration

  ON (B)(6) 2022 A PATIENT UNDERWENT A TOTAL DISK REPLACEMENT AT C5/6. AFTER A FOLLOW-UP APPOINTMENT ON (B)(6) 2023 IT WAS REPORTED THAT THERE WAS LOOSENING OF THE IMPLANT AND THE PATIENT'S PRE-OP SYMPTOMS WERE NOT RELIEVED. A REMOVAL SURGERY IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 16862379 ↗
• MalfunctionApr 14, 2023Migration; Migration

  ON (B)(6) 2022 A CT SCAN WAS DONE DUE TO NO RELIEF FROM CONTINUED NECK AND SHOULDER PAIN 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. (1 OF 2 200068992)

  Patient problems: Limb Pain; Neck Pain

  MAUDE report 16747786 ↗
• MalfunctionApr 14, 2023Migration; Migration

  ON (B)(6) 2021, THE PATIENT UNDERWENT DUAL VERTEBRAL DISC REPLACEMENTS AT C5/6 AND C6/7 WITH THE SIMPLIFY ARTIFICIAL DISCS. ON (B)(6) 2022, AN X-RAY WAS PERFORMED DUE TO CONTINUED NECK PAIN, LOCALIZED ON THE RIGHT SIDE, CAUSING PAIN INTO RIGHT SHOULDER AND DOWN THE RIGHT ARM. THE ACCORDING TO THE PATIENT THE NEUROSURGEON STATED THE ARTIFICIAL DISC AT C6/7 HAD SLIPPED OUT OF PLACE. ON (B)(6) 2022, A REVISION TOOK PLACE WHERE THE C6/7 DISC WAS REMOVED AND REPLACED.

  Patient problems: Limb Pain; Neck Pain

  MAUDE report 16746821 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT CONTINUED TO EXPERIENCE NECK AND TRAPEZIUS PAIN AFTER A SIMPLIFY DISC INDEX PROCEDURE AT C4/5. AS A RESULT, THE SIMPLIFY DISC WAS REMOVED APPROXIMATELY 2.5 MONTHS AFTER IMPLANTATION. DURING REMOVAL SURGERY, NO IMPLANT MIGRATION WAS NOTED, WHEN COMPARED TO IMMEDIATE POST-OP FILMS FROM THE INDEX PROCEDURE, AND THE DEVICE WAS FOUND INTACT WITH NO OBSERVABLE DISRUPTION TO SURROUNDING TISSUE. THERE WERE NO COMPLICATIONS DURING DEVICE REMOVAL. NO FURTHER PATIENT ADVERSE IMPACT WAS REPORTED.

  Patient problems: Neck Pain; Pain

  MAUDE report 13573630 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200022. One submission often covers many models, so check the product and lot details in each record.

• Z-1453-2022 · Jun 20, 2022 · Open, Classified
  Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht