Prodisc C SK PDSMD7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193113900), received between Mar 6, 2026 and Mar 6, 2026 — classified as 1 injury.

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 6, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (55 YEARS, FEMALE) WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. PATIENT HAD LINGERING PAIN AND THE SURGEON WAS CONCERNED ABOUT A POSSIBLE INFECTION. AN EXPLORATORY REVISION SURGERY WAS SCHEDULED. THERE WERE NO VISIBLE SIGNS OF INFECTION BUT THE PATIENT HAD POOR BONE QUALITY. C6-7 WAS REMOVED AND THE AREA SWABBED FOR CULTURES, DURING THE REMOVAL SURGERY THE SURGEON DECIDED TO REMOVE THE C5-6 LEVEL AS WELL. THE SK DEVICES WERE REPLACED WITH CAGES AND THEN THE PATIENT WAS CLOSED AND FLIPPED AND POSTERIOR FIXATION WAS ADDED. PATIENT WAS GIVEN ORAL ANTIBIOTICS TO START WHILE WAITING FOR CULTURES TO BE RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24532157 ↗

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-2051-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
• Z-2050-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 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