Prodisc C 09.820.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843193112767), received between Dec 8, 2020 and Nov 26, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT (33YO, FEMALE) WAS IMPLANTED WITH A PRODISC C IMPLANT AT C5-6 ON (B)(6) 2024. PATIENT HAD DIFFICULTY SWALLOWING AND IT WAS FOUND THAT THE IMPLANT HAD EXPULSED. SURGEON REMOVED THE IMPLANT AND FUSED THE PATIENT ON (B)(6) 2024.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 20786438 ↗
• InjuryJul 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A PATIENT WAS IMPLANTED WITH A PRODISC C IMPLANT ON (B)(6) 2021 AT C4-5. PATIENT BEGAN EXPERIENCING SYMPTOMS IN LINE WITH FACET PAIN AND IT WAS NOTED BY THE REMOVAL SURGEON THAT THE IMPLANT WAS TOO LARGE AND CAUSING PAIN. SURGEON REMOVED THE IMPLANT ON (B)(6) 2024 AND FUSED THE PATIENT WITH A MEDTRONIC ACDF DEVICE.

  Patient problems: Pain

  MAUDE report 19766639 ↗
• InjuryNov 30, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DEVICES WERE IMPLANTED ON (B)(6) 2019 BY DR.(B)(6). IMAGES WERE PROVIDED OF THE DEVICES PRIOR TO REMOVAL. THERE IS NO INDICATION OF A MALFUNCTION OF THE DEVICES AND THE DEVICES APPEAR TO BE IN GOOD POSITIONING. THE PATIENT IS EXPERIENCING PAIN. THE SOURCE OF THE PAIN MAY BE ATTRIBUTED TO OVER DISTRACTED FACETS. THE REPORTER INDICATES THIS IS EVIDENT IN THE X-RAY PROVIDED. THE IMPLANTS ARE 6MM HEIGHT WHICH IS NOT THE SMALLEST OFFERING. THE FACETS ARE OVER DISTRACTED DUE TO THE HEIGHT OF THE IMPLANTS. THUS THE DEVICES ARE CONTRIBUTING TO THE PATIENT'S PAIN. THERE WERE NO INDICATED PATIENT COMORBIDITIES OR PRE-EXISTING CONDITIONS. THE PATIENT HAD MOBI-C DEVICES IMPLANTED IN BOTH LEVELS PRIOR TO PRODISC C IMPLANTATION. THE PATIENT HAD MOBI-C IMPLANTED ON AN UNKNOWN DATE AT C4/5 AND C5/6. THESE WERE REPLACED WITH PDC DEVICES ON (B)(6) 2019, AND THEN REPLACED WITH PLATE AND ALLOGRAFT SPACER ON (B)(6) 2021. THE PATIENT UNDERWENT REVISION AND REMOVAL OF A 2-LEVEL PRODISC C CONSTRUCT AT C4/5 AND C5/6 ON (B)(6) 2021. THE DEVICES WERE REMOVED DUE TO PATIENT PAIN WHICH IS BELIEVED TO BE FROM OVER DISTRACTED FACETS. THE PRODISC C DEVICES WERE REPLACED WITH ACDF USING A PLATE AND ALLOGRAFT S

  Patient problems: Neck Pain

  MAUDE report 12897260 ↗
• InjuryNov 30, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DEVICES WERE IMPLANTED ON (B)(6) 2019 BY DR. (B)(6) . IMAGES WERE PROVIDED OF THE DEVICES PRIOR TO REMOVAL. THERE IS NO INDICATION OF A MALFUNCTION OF THE DEVICES AND THE DEVICES APPEAR TO BE IN GOOD POSITIONING. THE PATIENT IS EXPERIENCING PAIN. THE SOURCE OF THE PAIN MAY BE ATTRIBUTED TO OVER DISTRACTED FACETS. THE REPORTER INDICATES THIS IS EVIDENT IN THE X-RAY PROVIDED. THE IMPLANTS ARE 6MM HEIGHT WHICH IS NOT THE SMALLEST OFFERING. THE FACETS ARE OVER DISTRACTED DUE TO THE HEIGHT OF THE IMPLANTS. THUS THE DEVICES ARE CONTRIBUTING TO THE PATIENT'S PAIN. THERE WERE NO INDICATED PATIENT COMORBIDITIES OR PRE-EXISTING CONDITIONS. THE PATIENT HAD MOBI-C DEVICES IMPLANTED IN BOTH LEVELS PRIOR TO PRODISC C IMPLANTATION. THE PATIENT HAD MOBI-C IMPLANTED ON AN UNKNOWN DATE AT C4/5 AND C5/6. THESE WERE REPLACED WITH PDC DEVICES ON (B)(6) 2019, AND THEN REPLACED WITH PLATE AND ALLOGRAFT SPACER ON (B)(6) 2021. THE PATIENT UNDERWENT REVISION AND REMOVAL OF A 2-LEVEL PRODISC C CONSTRUCT AT C4/5 AND C5/6 ON (B)(6) 2021. THE DEVICES WERE REMOVED DUE TO PATIENT PAIN WHICH IS BELIEVED TO BE FROM OVER DISTRACTED FACETS. THE PRODISC C DEVICES WERE REPLACED WITH ACDF USING A PLATE AND ALLOGRAFT

  Patient problems: Neck Pain

  MAUDE report 12897204 ↗
• InjuryDec 8, 2020Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  A PATIENT UNDERWENT A PRODISC C REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO IMPLANT SUBSIDENCE AND MIGRATION. THE SUPERIOR ENDPLATE SUBSIDED INTO THE C5 VERTEBRAE AND MIGRATED ANTERIORLY. THE PATIENT EXPRESSED NECK AND ARM PAIN WHICH LED TO THE SURGEON'S DECISION TO EXPLANT THE PRODISC C AND REPLACE IT WITH A 3D PRINTED CAGE AND PLATE.

  Patient problems: Neck Pain; Pain

  MAUDE report 10969561 ↗

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