Prodisc C SK PDSXL5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843193113979), received between Feb 6, 2025 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 20, 2026Open, Classified

   Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

   Z-2050-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

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.

• MalfunctionMar 30, 2026Device Misassembled During Manufacturing /Shipping

  A PATIENT (20YO, MALE) WAS IMPLANTED WITH TWO PRODISC C SK DEVICES ON (B)(6) 2026. BOTH IMPLANTS WERE LABELED AS 5MM DEVICES BUT ONCE PLACED IT WAS EVIDENT THAT ONE IMPLANT WAS TALLER THAN THE OTHER. INVESTIGATION FOUND THAT THE ONE IMPLANT WAS 6MM BUT LABELED AS 5MM. THE SURGEON STATED TO LEAVE THE IMPLANT ALONE. HE SAID THE HEIGHT IS FINE AND THAT THE PATIENT COULD TAKE A 5 OR 6MM DEVICE. HE SAID HE WOULD HAVE PULLED IT OUT IF HE THOUGHT IT WOULD HURT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715993 ↗
• MalfunctionFeb 6, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 AND TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6)2024. IT WAS FOUND THAT THE VIVO IMPLANT HAD MIGRATED ANTERIORALLY, THE SK IMPLANT AT C5-6 WAS KYPHOTIC, AND THE SK IMPLANT AT C6-7 HAD MIGRATED POSTERIORLY AND SUBSIDED. A SECOND SURGEON RECOMMENDED REMOVING ALL THREE LEVELS AND FUSING C6-7 AND CONVERTING C4-5 AND C5-6 TO PDC ORIGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Spinal Column Injury

  MAUDE report 21327002 ↗
• MalfunctionFeb 6, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 AND TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. IT WAS FOUND THAT THE VIVO IMPLANT HAD MIGRATED ANTERIORALLY, THE SK IMPLANT AT C5-6 WAS KYPHOTIC, AND THE SK IMPLANT AT C6-7 HAD MIGRATED POSTERIORALLY AND SUBSIDED. A SECOND SURGEON RECOMMENDED REMOVING ALL THREE LEVELS AND FUSING C6-7 AND CONVERTING C4-5 AND C5-6 TO PDC ORIGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Spinal Column Injury

  MAUDE report 21326996 ↗

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-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