Prodisc C SK PDSLD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193113948), received between Sep 11, 2024 and Apr 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Inadequacy of Device Shape and/or Size

  A PATIENT (39 YO FEMALE) WAS IMPLANTED WITH A TWO PRODISC C SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. THREE MONTHS LATER, ON (B)(6) 2024, THE PATIENT HAD A REMOVAL OF THE C5-6 SK IMPLANT, WHICH WAS REPLACED BY A SECOND SK IMPLANT ON A LARGER HEIGHT. THIS REMOVAL WAS IDENTIFIED DURING THE INVESTIGATION OF (B)(4), WHICH WAS A RECENT REMOVAL COMPLETED ON THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25027920 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PRODISC C SK IMPLANT AT LEVEL C4-5 ON (B)(6) 2024. THE PATIENT HAD CONTINUOUS NECK PAIN AND LOTS OF SCAR TISSUE. NO MALFUNCTION OR DEFECT WAS SEEN WITH THE SK IMPLANT. THE SURGEON MADE THE DECISION TO REMOVE THE IMPLANT AND FUSE THE PATIENT. THE IMPLANT WAS REMOVED ON (B)(6) 2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20195429 ↗

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