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ProDisc-C 09.820.076SRecalls & reported problems

Synthes (U.S.A.) LP · PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE · Class 3 · Implant

All models of ProDisc-C (11)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034763880), received between Oct 3, 2018 and Oct 3, 2018 — classified as 1 injury.

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

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PRODISC-C REVISION PROCEDURE BECAUSE THERE WAS A BONE SPUR THAT WAS CAUSING STENOSIS. THE PRODISC-C IMPLANT WAS IN GOOD POSITION, BUT THEY COULD NOT DECOMPRESS WITHOUT REMOVING IT. THE IMPLANT WAS SUCCESSFULLY REMOVED AND WITHOUT BONE FRAGMENTS. THE PATIENT WAS REVISED TO A FUSION WITH INTERBODY AND PLATE. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND THERE WERE NO OTHER INTERVENTIONS REQUIRED. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Code Available

    MAUDE report 7931923 ↗

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

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