Prodisc C 09.820.045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843193112811), received between Mar 4, 2021 and Nov 30, 2023 — classified as 5 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (P070001); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C4-5 ON (B)(6) 2023. PATIENT HAD LINGERING RADICULAR SYMPTOMS BUT DEVELOPED AN URGENT SWALLOWING ISSUE AT 7 MONTHS POST OP. IT WAS DETERMINED THAT THE IMPLANT MIGRATED TO A 90% EGRESS OF THE ADR. PATIENT WAS REVISED TO AN ACDF ON 02NOV2023.

  Patient problems: Dysphagia/ Odynophagia; Neck Pain

  MAUDE report 18237628 ↗
• InjuryAug 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C6-C7 ON (B)(6) 2021. THE IMPLANT WAS REMOVED ON (B)(6) 2023. NO INFORMATION OR IMAGING WAS PROVIDED TO DETAIL THE PATIENT'S CONDITION OR REASON FOR THE REMOVAL. THE IMPLANT WAS REPLACED WITH A FUSION DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17461045 ↗
• InjuryMar 24, 2022Biocompatibility; Biocompatibility

  ON (B)(6) 2022 THE SURGEON SCHEDULED A 2 LEVEL PDC, ADJACENT LEVELS ABOVE AND BELOW A PREVIOUS FUSION OF C5-7. THE PATIENT HAD AN EXISTING PLATE AND CORPECTOMY CAGE (ALL TITANIUM ALLOY IMPLANTS). BEFORE STARTING THE CASE, THE SURGEON ASKED WHAT THE NICKEL CONTENT IS IN THE PRODISC C. A LETTER STATING 0.18% IN CO-28CR-6MO COBALT CHROMIUM WAS PROVIDED TO THE SURGEON. THE PATIENT HAD A POSSIBLE NICKEL ALLERGY, BUT STATED THAT IT WAS MOSTLY A SKIN REACTION TO SOME JEWELRY. SURGEON IMPLANTED 2 PRODISC C IMPLANTS PER SCHEDULED PROCEDURE. TWO WEEKS POST OP, THE PATIENT HAS BEEN COMPLAINING AND TREATED FOR FACE NECK AND UPPER CHEST RASHES AND IRRITATION. PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS AS IT WAS THOUGHT IT MAY BE A POSSIBLE SURGICAL SITE INFECTION. SINCE FINISHING THE COURSE OF MEDICATIONS, THE IRRITATION, RASH AND SWELLING AROUND THE EYES HAS WORSENED. PATIENT HAD ALL NECK AND ARM PAIN AND ISSUES WERE RESOLVED COMPLETELY WITH THE 2-LEVEL PRODISC C. PATIENT IS DOING VERY WELL FROM THAT ASPECT. NO INDICATION OF SURGICAL INTERVENTION.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 13891603 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED AN UNKNOWN PRODISC C IMPLANT ON AN UNKNOWN DATE. DUE TO UNKNOWN REASONS, THE PATIENT WAS DIAGNOSED FOR PRODISC C REMOVAL. LITTLE INFORMATION ABOUT THIS CASE HAS BEEN PROVIDED. THE PATIENT WAS EXPERIENCING PAIN, BUT THERE WAS NO CLEAR REASON WHY THE DEVICE WAS REMOVED. DATA FORMS FROM THE FACILITY INDICATE DEVICE REMOVAL DUE TO FAILED CERVICAL FUSION; HOWEVER, IT IS NOT CLEAR IF THERE WAS AN ADJACENT FUSION AS THIS DEVICE IS NOT A CERVICAL FUSION DEVICE. THERE WAS NO INDICATION WHETHER THE DEVICE WAS CAUSING OR CONTRIBUTING TO THE PATIENT'S PAIN. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE PRODISC C DEVICE WAS REMOVED ON (B)(6) 2020. THE REPLACEMENT DEVICE OR PROCEDURE IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12183554 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A PRODISC C US IMPLANT LARGE 5MM. THE PATIENT WAS INITIALLY IMPLANTED WITH THE DEVICE ON (B)(6) 2020 TO ADDRESS C6 ROOT PAIN. THE PAIN DID NOT SUBSIDE UP TO 6 WEEK FOLLOW UP WHEN THE DECISION TO REVISE THE PATIENT TO A FUSION WAS MADE. THE PATIENT WAS REVISED ON (B)(6) 2021. NO COMPLICATIONS WERE INDICATED FROM THE REVISION PROCEDURE.

  Patient problems: Neck Pain; Pain

  MAUDE report 11415507 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P070001. One submission often covers many models, so check the product and lot details in each record.

• Z-2050-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
• Z-2051-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
• Z-1426-2026 · Dec 31, 2025 · Open, Classified
  Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
• Z-1406-2021 · Mar 5, 2021 · Terminated
  Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for