Prodisc C SK PDSXLD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193114006), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryApr 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT, (39-YEAR-OLD 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. DURING THE SECOND SURGERY AN SK IMPLANT WAS ALSO PLACED AT C4-5. THE PATIENT THEN HAD A THREE LEVEL CONSTRUCT OF SK DEVICES FROM C4-7. APPROXIMATELY TWO YEARS LATER THE PATIENT HAD SOME ON-GOING PAIN. THE SURGEON WANTED TO REMOVE ALL THREE DEVICES AND FUSE THE PATIENT. ON (B)(6) 2026, THE SURGEON OPENED THE PATIENT AND FOUND THAT THE IMPLANT AT C6-7 HAD NOT FIXATED AND MAY HAVE BEEN INFECTED. THE IMPLANTS AT C4-5 AND C5-6 LOOKED GOOD AND WERE LEFT IN PLACE. THE C6-7 IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED AT THAT LEVEL. THE SK DEVICE WAS SENT FOR CULTURES AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24764827 ↗

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