Prodisc C 09.820.075SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193112903), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 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 SAID 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 THOUGHT IT MAY BE A POSSIBLE SURGICAL SITE INFECTION. SINCE FINISHING THE COURSE OF MEDICATION, THE IRRITATION, RASH AND NOW SWELLING AROUND THE EYES HAS WORSENED. PATIENT HAD ALL NECK AND ARM PAIN AND ISSUES 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 13906428 ↗

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