Prodisc C 09.820.076SRecalls & reported problems
Centinel Spine, LLC · PRODISC-C IMPLANT EXTRA 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
- 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 00843193112910), received between Jun 25, 2026 and Jun 25, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Neck Pain1
- Neuropathy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2026Off-Label Use
A PATIENT (70 YO, FEMALE) WAS IMPLANTED WITH A PDC DEVICE AT LEVEL C3-4 ON (B)(6) 2023. PATIENT HAS A HISTORY OF MULTIPLE SPINAL FUSIONS IN HER CERVICAL, THORACIC, AND LUMBAR SPINE AS WELL AS OSTEOPOROSIS AND LEFT SACROILIITIS. PATIENT HAD BEEN EXPERIENCING NECK PAIN, AND NUMBNESS AND TINGLING IN ARMS AND HANDS, AND DAILY HEADACHES. THE SURGEON COMPLETED A PDC REMOVAL ON (B)(6) 2026 AND FUSED THE PATIENT.
Patient problems: Neck Pain; Neuropathy
MAUDE report 25627117 ↗
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, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Z-2050-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Z-1426-2026 · Dec 31, 2025 · Open, ClassifiedBrand 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 · TerminatedProdisc 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
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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