ProDisc-C 09.820.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034763736), received between Apr 3, 2019 and Nov 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021 A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6. THE PATIENT COMPLAINED OF NECK PAIN AND RIGHT SIDED RADICULOPATHY PAIN. IT WAS FOUND THAT THE SUPERIOR ENDPLATE SHOWED SUBSIDENCE AND INSTABILITY. THE PDC DEVICE WAS REMOVED ON (B)(6) 2023, PATIENT WAS REVISED TO A CAGE AND PLATE SYSTEM.

  Patient problems: Neck Pain

  MAUDE report 18237495 ↗
• InjuryJun 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6 ON (B)(6) 2021. THE IMPLANT WAS REMOVED ON (B)(6) 2023. NO STATED REASON FOR REMOVAL WAS PROVIDED, X-RAY IMAGES WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17049194 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT C5/C6 PRODISC-C REMOVAL DUE TO CONTINUED PAIN AND RADICULAR SYMPTOMS. ORIGINALLY, THE PATIENT UNDERWENT IMPLANTATION ON, (B)(6) 2013. THE PATIENT DEVELOPED NECK PAIN 2 YEARS AFTER IMPLANTATION AND SURGEON OFFERED TO REMOVE AND FUSE. HOWEVER, THE PATIENT DECIDED TO GO FORWARD WITH CONSERVATIVE MEASURES, EPIDURAL STEROID INJECTIONS, ETC. RECENTLY THE PATIENT HAD INCREASED PAIN AND WENT TO THE SURGEON. LATERAL X-RAY WAS TAKEN ON AN UNKNOWN DATE, AND THE REMOVAL SURGERY WAS SCHEDULED ON (B)(6) 2019. THE IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT WAS REVISED TO FUSION USING MEDTRONIC CAGE AND PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT WAS STABLE AFTER THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8480546 ↗

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