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Prodisc C 09.820.056SRecalls & reported problems

Centinel Spine, LLC · PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE · Class 3 · Implant

All models of Prodisc C (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193112859), received between Mar 8, 2021 and Nov 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Failure to Osseointegrate1
  • Insufficient Device Problem Information1
  • Migration or Expulsion of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Paralysis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PDC IMPLANTATION AT C5-7. THE IMPLANTATION WAS COMPLETED ON (B)(6) 2022. FOLLOWING THE PROCEDURE THE PATIENT IS PARALYZED. SEVERAL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION BUT IT IS UNKNOWN WHAT OCCURRED INTRAOPERATIVELY.

    Patient problems: Paralysis

    MAUDE report 15819192 ↗
  • InjuryMar 8, 2021Migration or Expulsion of Device; Failure to Osseointegrate; Migration or Expulsion of Device; Failure to Osseointegrate

    THE PATIENT HAD PREVIOUSLY UNDERWENT A REVISION ON (B)(6) 2021 TO REPLACE A 5MM PDC IMPLANT WITH A 6MM. THE PREVIOUS 5MM IMPLANT WAS IMPLANTED ON (B)(6) 2020. THE 1ST REVISION WAS DUE TO A PATIENT FALL WHICH CAUSED ANTERIOR MIGRATION OF THE PRODISC C IMPLANT OUT OF THE DISC SPACE. THE PATIENT THEN SUFFERED ANOTHER MIGRATION OF THE 6MM PDC IMPLANT DUE TO UNKNOWN REASONS. THE PATIENT WAS REVISED TO A FUSION USING UNKNOWN DEVICES ON (B)(6) 2021. THE PATIENT DID NOT HAVE ANY COMORBIDITIES OR ANY COMPLICATIONS OR SYMPTOMS AS A RESULT OF THE MIGRATION. THE IMAGING FROM BOTH PDC REVISION CASES INDICATED THE DEVICE MIGRATED ANTERIORLY APPROXIMATELY 50% OF THE IMPLANT AP DEPTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11440261 ↗

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

Other Prosthesis, Intervertebral Disc devices

All Prosthesis, Intervertebral Disc devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page