Prodisc C SK PDSM5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843193113856), received between Aug 14, 2024 and Nov 12, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jul 18, 2024Open, Classified

   During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

   Z-3212-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Jul 18, 2024Open, Classified

   During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

   Z-3213-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. PATIENT STATED THAT WHEN SHE AWOKE FROM IMPLANTATION SURGERY, SHE WAS PARALYZED WITH ONLY THE ABILITY TO MOVE HER EYES. PATIENT STATED THAT THE SURGEON TOLD HER THAT THE IMPLANT WAS PUSHED TOO FAR POSTERIOR, AND THAT THE IMPLANT HAD SMASHED HER SPINE, AND HE HAD TO TAKE IT OUT. PATIENT SPENT ONE WEEK IN THE ICU, FOLLOWED BY A MONTH AT A SPINE REHAB CENTER, PATIENT CONTINUES TO GO TO PT THREE TIMES A WEEK AND HAS BEEN UNABLE TO RETURN TO WORK. PATIENT HAD TO RELEARN HOW TO WALK AND CONTINUES TO HAVE ARM AND HAND NUMBNESS.

  Patient problems: Paralysis

  MAUDE report 23538309 ↗
• InjuryNov 12, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. PATIENT STATED THAT WHEN SHE AWOKE FROM IMPLANTATION SURGERY, SHE WAS PARALYZED WITH ONLY THE ABILITY TO MOVE HER EYES. PATIENT STATED THAT THE SURGEON TOLD HER THAT THE IMPLANT WAS PUSHED TOO FAR POSTERIOR, AND THAT THE IMPLANT HAD SMASHED HER SPINE, AND HE HAD TO TAKE IT OUT. PATIENT SPENT ONE WEEK IN THE ICU, FOLLOWED BY A MONTH AT A SPINE REHAB CENTER, PATIENT CONTINUES TO GO TO PT THREE TIMES A WEEK AND HAS BEEN UNABLE TO RETURN TO WORK. PATIENT HAD TO RELEARN HOW TO WALK AND CONTINUES TO HAVE ARM AND HAND NUMBNESS.

  Patient problems: Paralysis

  MAUDE report 23538306 ↗
• MalfunctionSep 18, 2025Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE AT C5-6 ON (B)(6) 2025. AT THE 2 WEEK FOLLOW UP, THE IMAGING SHOWED THAT THE IMPLANT MAY HAVE SLIGHTLY SUBSIDED AND KYPHOSED. THE PATIENT IS EXPERIENCING NO SYMPTOMS AND IS DOING WELL. THERE IS NO INDICATION AT PRESENT THAT ANY INTERVENTION WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084969 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE ON (B)(6) 2024. FOLLOWING IMPLANTATION THE PATIENT HAD PERSISTENT ONGOING PAIN. NO MALFUNCTION, MIGRATION, OR PROBLEM WITH THE DEVICE. THE SURGEON REMOVED THE IMPLANT ON (B)(6) 2024 AND FUSED THE PATIENT WITH A PEEK SPACER AND PLATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19982946 ↗

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