Prodisc C SK PDSMD5Recalls & reported problems
Centinel Spine, LLC · Prodisc C SK, Medium Deep, 5mm · Class 3 · Implant
Data updated Oct 13, 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 00843193113887), received between Oct 18, 2024 and Oct 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Limb Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE ON (B)(6) 2024 AT THE C5-6 LEVEL. PATIENT WAS EXPERIENCING RECURRING RADICULAR PAIN ON THE OTHER SIDE OF THE BODY FROM THE INITIAL SURGERY. IT WAS FOUND THAT THE DEVICE MAY HAVE BEEN UNDERSIZED AND TILTING TO ONE SIDE, LEADING TO THE PATIENT'S SYMPTOMS. THE SURGEON REMOVED THE IMPLANT ON (B)(6) 2024 AND FUSED THE PATIENT WITH A PLATE AND CAGE SYSTEM.
Patient problems: Limb Pain
MAUDE report 20480393 ↗
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-2050-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Z-2051-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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