Prodisc C 09.820.055SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00843193112842), received between Jan 27, 2021 and Jul 5, 2023 — classified as 9 injuries.

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

1 FDA recall record name this device's identifier.

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 5, 2021Terminated

   Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.

   Z-1406-2021 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2023Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-C6 ON (B)(6) 2021. THE IMPLANT WAS REMOVED ON (B)(6) 2023. THE PATIENT PRESENTED WITH RADICULOPATHY AND KYPHOSIS AT THE C5-C6 INDEX LEVEL WHERE THE DEVICE WAS IMPLANTED. X-RAY IMAGES WERE PROVIDED. THE REASON FOR THE REMOVAL WAS THE IMPLANT HAD MIGRATED POSTERIORLY AND THE SURGEON NOTED DURING THE REMOVAL SURGERY THAT THE ENDPLATES OF THE PRODISC C DEVICE WERE NOT INTEGRATED WITH THE BONE FROM THE VERTEBRAL BODIES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17259951 ↗
• 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 15819361 ↗
• InjuryFeb 23, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  THE PATIENT WAS IMPLANTED WITH 2X PRODISC C US IMPLANT LARGE-DEEP 5MM AT C5/6 AND C6/7 ON (B)(6) 2019. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED TO NEED REVISION/REMOVAL OF THE PRODISC C DEVICE. THE DIAGNOSIS WAS DUE TO PAIN IN BOTH ARMS, POSTERIOR DISPLACEMENT, AND DEVICE SHIFTING. THE PATIENT DID NOT HAVE ANY COMORBIDITIES. X-RAY IMAGES PROVIDED SUGGEST THE PDC DEVICE AT C6/7 WAS POSITIONED TOO FAR POSTERIOR. THE IMAGES SHOW THE SUPERIOR ENDPLATE CANTED FORWARD IN A NEUTRAL NECK POSITION. ADDITIONALLY THE X-RAYS SHOW SIGNIFICANT DEGENERATION AT C4/5 AS WELL AS HETEROTOPIC OSSIFICATION ANTERIOR TO THE PDC IMPLANTS. ON (B)(6) 2022 THE PATIENT UNDERWENT PRODISC C REMOVAL OF THE C6/7 IMPLANT. THE PRODISC C WAS REPLACED WITH A CORPECTOMY CAGE AND PLATE FROM AN UNKNOWN MANUFACTURER (NOT CENTINEL SPINE, LLC.). THERE IS NO INDICATION THE C5/6 DEVICE WAS REMOVED.

  Patient problems: Neck Pain

  MAUDE report 13587945 ↗
• InjurySep 24, 2021Malposition of Device; Malposition of Device

  PRODISC C REMOVAL SCHEDULED WITH DR. (B)(6) ON MONDAY (B)(6) 2021. THE PRODISC C IMPLANTED AT C4-5 WAS PLACED OFF OF MIDLINE, AND THE PATIENT HAS REPORTED SOME RADICULAR PAIN. IMAGING PROVIDED SHOWS THE C4-5 IMPLANT OFF MIDLINE TO THE PATIENT'S LEFT SIDE. THE IMPLANT MAY ALSO BE ROTATED. THE DECISION TO COMPLETE THE REMOVAL WAS MADE ON (B)(6) 2021. THERE HAS BEEN NO INDICATION THAT THERE WAS A PROBLEM OR MALFUNCTION WITH THE DEVICE. PATIENT HAS NO COMORBIDITIES OR PRE-EXISTING CONDITIONS THAT MAY HAVE AFFECTED THE DEVICE. THE SURGEON IS GOING TO REPLACE THE PDC DEVICE WITH A FUSION DEVICE. IT IS UNKNOWN WHAT CAUSED THE DEVICE TO BE PLACED OFF MIDLINE. IT IS POSSIBLE THE PATIENT ANATOMY OR IMAGING AVAILABLE WAS A FACTOR THOUGH THERE WAS NO INDICATION OF A IMPLANT OR INSTRUMENT MALFUNCTION DURING THE IMPLANTATION CASE. THE REMOVAL WAS COMPLETED ON (B)(6) 2021 WITH NO COMPLICATIONS. THE DEVICE WAS OFF MIDLINE LATERALLY, AND THE SURGEON FELT THE POSITIONING WAS CONTACTING A NERVE ROOT. THE SURGEON WAS NOT HAPPY WITH THE POSITIONING THUS DECIDED TO REMOVE THE PRODISC C AND REPLACE IT WITH AN UNKNOWN STANDALONE FUSION DEVICE. THERE WAS NO INDICATION THAT THE PATIENT WAS EXPERIENCING SYMP

  Patient problems: Pain

  MAUDE report 12526758 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A PRODISC C IMPLANT ON (B)(6) 2011. IMAGING PROVIDED SHOWS THE PRODISC C DEVICE IS BELOW A 2-LEVEL ACDF USING PLATE AND CAGE. IT IS NOT KNOWN IF THE ACDF WAS PERFORMED BEFORE OR AFTER PRODISC C IMPLANTATION. THE PATIENT WAS SCHEDULED FOR REMOVAL DUE TO NECK PAIN AND POSTERIOR OSSIFICATION TO THE PRODISC C DEVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. IT IS UNKNOWN IF THE DEVICE WAS CONTRIBUTING TO THE PATIENT'S PAIN. PATIENT'S SIZE/WEIGHT MAY HAVE BEEN A CONTRIBUTING FACTOR. PRODISC C REMOVAL WAS COMPLETED ON (B)(6) 2021 THE PRODISC C DEVICE WAS REPLACED WITH A STANDALONE FUSION USING ROI-C DEVICE.

  Patient problems: Extraskeletal ossification; Neck Pain

  MAUDE report 12319035 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DIAGNOSED/SCHEDULED FOR PRODISC C REMOVAL ON AN UNKNOWN DATE. REMOVAL WAS TO TAKE PLACE ON (B)(6) 2021 DUE TO NECK PAIN AND RADICULOPATHY. THERE WAS NO INDICATION OF DEVICE MALFUNCTION OR DEVICE PROBLEMS. IT IS UNKNOWN IF THE DEVICE WAS CAUSING/CONTRIBUTING TO THE NECK PAIN OR RADICULOPATHY. PRODISC C REMOVAL WAS SUCCESSFULLY COMPLETED ON (B)(6) 2021. THE 2-LEVEL PRODISC C CONSTRUCT WAS REMOVED FROM C5/6 AND C6/7. THERE WAS NO INDICATION WHAT THE DEVICES WERE REPLACED WITH.

  Patient problems: Neck Pain; Nerve Damage

  MAUDE report 12051410 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DIAGNOSED/SCHEDULED FOR PRODISC C REMOVAL ON AN UNKNOWN DATE. REMOVAL WAS TO TAKE PLACE ON (B)(6) 2021 DUE TO NECK PAIN AND RADICULOPATHY. THERE WAS NO INDICATION OF DEVICE MALFUNCTION OR DEVICE PROBLEMS. IT IS UNKNOWN IF THE DEVICE WAS CAUSING/CONTRIBUTING TO THE NECK PAIN OR RADICULOPATHY. PRODISC C REMOVAL WAS SUCCESSFULLY COMPLETED ON (B)(6) 2021. THE 2-LEVEL PRODISC C CONSTRUCT WAS REMOVED FROM C5/6 AND C6/7. THERE WAS NO INDICATION WHAT THE DEVICES WERE REPLACED WITH.

  Patient problems: Neck Pain; Nerve Damage

  MAUDE report 12051409 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A PRODISC C US IMPLANT AT THE C4/5 LEVEL ON (B)(6) 2020. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH HETEROTOPIC OSSIFICATION AT THE PRODISC C LEVEL. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2021 TO REMOVE THE PRODISC C IMPLANT AND REPLACE IT WITH A SYNTHES ZERO P CAGE AND SCREWS.

  Patient problems: Extraskeletal ossification

  MAUDE report 11938766 ↗
• InjuryJan 27, 2021Migration; Migration

  A PATIENT RECEIVED A PRODISC C US IMPLANT LARGE DEEP 5MM ON (B)(6) 2020. AT THE PATIENTS 3 MONTH FOLLOW UP APPOINTMENT, IMAGING REVEALED THE PRODISC C DEVICE MIGRATED ANTERIORLY OUT OF THE DISC SPACE. AT THE FOLLOW UP APPOINTMENT, THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE MIGRATED DEVICE. THE PATIENT INFORMED THE SURGEON THEY HAD SUFFERED A FALL PREVIOUSLY THAT MAY HAVE CONTRIBUTED TO THE MIGRATION OF THE DEVICE. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE 5MM HEIGHT IMPLANT WITH A PRODISC C US IMPLANT LARGE DEEP 6MM. THE REVISION WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT CONDITION POST REVISION HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238113 ↗

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