Prodisc C SK PDSL6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193113924), received between Feb 11, 2026 and Feb 11, 2026 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 31, 2025Open, Classified

   Products were mislabeled as the 6mm product but included the 5 mm product.

   Z-1426-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionFeb 11, 2026Osseointegration Problem

  A PATIENT (49YO, FEMALE) WAS IMPLANTED WITH A PDC SK DEVICE AT C5-6 ON (B)(6) 2025. THIS IMPLANT WAS IDENTIFIED AS ONE OF THE LOT THAT WAS LABELED AS A 6MM HEIGHT BUT WAS ASSEMBLED AS A 5MM HEIGHT. THIS LOT IS UNDER A FSCA. AT THE (B)(6) 2025 FOLLOW-UP THE PATIENT REPORTED OVERALL IMPROVEMENT OF 80% AND STILL HAD SOME SPASMS AND MILD PAIN WITH EXTENSION. AT THE (B)(6) 2026 FOLLOW UP THE PATIENT REPORTED RIGHT HAND WEAKNESS AND SURGICAL SITE IRRITATION, THE PATIENT FELT LIKE THEY WERE REGRESSING. IMAGING FOUND THAT THE IMPLANT IS KYPHOTIC. SURGEON REPORTED THAT THE PATIENT HAS <1MM RANGE OF MOTION DUE TO THE KYPHOSIS. IF THE PATIENT'S SYMPTOMS DO NOT RESOLVE THE IMPLANT WILL BE REVISED.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 24318060 ↗

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-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