Prodisc C SKRecalls & reported problems across all models

We found 10 models of Prodisc C SK by Centinel Spine, LLC in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2024 and Apr 29, 2026 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (4 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Prodisc C SK recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 20, 2026Open, Classified

   Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

   Z-2051-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

2. Mar 20, 2026Open, Classified

   Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

   Z-2050-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

3. Dec 31, 2025Open, Classified

   Products were mislabeled as the 6mm product but included the 5 mm product.

   Z-1426-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Jul 18, 2024Open, Classified

   During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

   Z-3213-2024 · Root cause: Process control · Recall details · FDA record ↗

5. Jul 18, 2024Open, Classified

   During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

   Z-3212-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Prodisc C SK problems

Prodisc C SK models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Prodisc C SK PDSM5

  Prosthesis, Intervertebral Disc
  2 recalls4 reports
• Prodisc C SK PDSXL5

  Prosthesis, Intervertebral Disc
  1 recall3 reports
• Prodisc C SK PDSL6

  Prosthesis, Intervertebral Disc
  1 recall1 report
• Prodisc C SK PDSXL6

  Prosthesis, Intervertebral Disc
  1 recall1 report
• Prodisc C SK PDSL5

  Prosthesis, Intervertebral Disc
  2 reports
• Prodisc C SK PDSLD5

  Prosthesis, Intervertebral Disc
  2 reports
• Prodisc C SK PDSMD5

  Prosthesis, Intervertebral Disc
  1 report
• Prodisc C SK PDSMD7

  Prosthesis, Intervertebral Disc
  1 report
• Prodisc C SK PDSLD6

  Prosthesis, Intervertebral Disc
  1 report
• Prodisc C SK PDSXLD5

  Prosthesis, Intervertebral Disc
  1 report

Recent Prodisc C SK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Inadequacy of Device Shape and/or Size

  A PATIENT (39 YO FEMALE) WAS IMPLANTED WITH A TWO PRODISC C SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. THREE MONTHS LATER, ON (B)(6) 2024, THE PATIENT HAD A REMOVAL OF THE C5-6 SK IMPLANT, WHICH WAS REPLACED BY A SECOND SK IMPLANT ON A LARGER HEIGHT. THIS REMOVAL WAS IDENTIFIED DURING THE INVESTIGATION OF (B)(4), WHICH WAS A RECENT REMOVAL COMPLETED ON THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25027920 ↗
• InjuryApr 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT, (39-YEAR-OLD FEMALE), WAS IMPLANTED WITH A TWO PRODISC C SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. THREE MONTHS LATER, ON (B)(6) 2024, THE PATIENT HAD A REMOVAL OF THE C5-6 SK IMPLANT, WHICH WAS REPLACED BY A SECOND SK IMPLANT ON A LARGER HEIGHT. DURING THE SECOND SURGERY AN SK IMPLANT WAS ALSO PLACED AT C4-5. THE PATIENT THEN HAD A THREE LEVEL CONSTRUCT OF SK DEVICES FROM C4-7. APPROXIMATELY TWO YEARS LATER THE PATIENT HAD SOME ON-GOING PAIN. THE SURGEON WANTED TO REMOVE ALL THREE DEVICES AND FUSE THE PATIENT. ON (B)(6) 2026, THE SURGEON OPENED THE PATIENT AND FOUND THAT THE IMPLANT AT C6-7 HAD NOT FIXATED AND MAY HAVE BEEN INFECTED. THE IMPLANTS AT C4-5 AND C5-6 LOOKED GOOD AND WERE LEFT IN PLACE. THE C6-7 IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED AT THAT LEVEL. THE SK DEVICE WAS SENT FOR CULTURES AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24764827 ↗
• MalfunctionMar 30, 2026Device Misassembled During Manufacturing /Shipping

  A PATIENT (20YO, MALE) WAS IMPLANTED WITH TWO PRODISC C SK DEVICES ON (B)(6) 2026. BOTH IMPLANTS WERE LABELED AS 5MM DEVICES BUT ONCE PLACED IT WAS EVIDENT THAT ONE IMPLANT WAS TALLER THAN THE OTHER. INVESTIGATION FOUND THAT THE ONE IMPLANT WAS 6MM BUT LABELED AS 5MM. THE SURGEON STATED TO LEAVE THE IMPLANT ALONE. HE SAID THE HEIGHT IS FINE AND THAT THE PATIENT COULD TAKE A 5 OR 6MM DEVICE. HE SAID HE WOULD HAVE PULLED IT OUT IF HE THOUGHT IT WOULD HURT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715993 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (55 YEARS, FEMALE) WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. PATIENT HAD LINGERING PAIN AND THE SURGEON WAS CONCERNED ABOUT A POSSIBLE INFECTION. AN EXPLORATORY REVISION SURGERY WAS SCHEDULED. THERE WERE NO VISIBLE SIGNS OF INFECTION BUT THE PATIENT HAD POOR BONE QUALITY. C6-7 WAS REMOVED AND THE AREA SWABBED FOR CULTURES, DURING THE REMOVAL SURGERY THE SURGEON DECIDED TO REMOVE THE C5-6 LEVEL AS WELL. THE SK DEVICES WERE REPLACED WITH CAGES AND THEN THE PATIENT WAS CLOSED AND FLIPPED AND POSTERIOR FIXATION WAS ADDED. PATIENT WAS GIVEN ORAL ANTIBIOTICS TO START WHILE WAITING FOR CULTURES TO BE RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24532157 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (55 YEARS, FEMALE) WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. PATIENT HAD LINGERING PAIN AND THE SURGEON WAS CONCERNED ABOUT A POSSIBLE INFECTION. AN EXPLORATORY REVISION SURGERY WAS SCHEDULED. THERE WERE NO VISIBLE SIGNS OF INFECTION BUT THE PATIENT HAD POOR BONE QUALITY. C6-7 WAS REMOVED AND THE AREA SWABBED FOR CULTURES, DURING THE REMOVAL SURGERY THE SURGEON DECIDED TO REMOVE THE C5-6 LEVEL AS WELL. THE SK DEVICES WERE REPLACED WITH CAGES AND THEN THE PATIENT WAS CLOSED AND FLIPPED AND POSTERIOR FIXATION WAS ADDED. PATIENT WAS GIVEN ORAL ANTIBIOTICS TO START WHILE WAITING FOR CULTURES TO BE RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24532155 ↗
• MalfunctionFeb 11, 2026Osseointegration Problem

  A PATIENT (49YO, FEMALE) WAS IMPLANTED WITH A PDC SK DEVICE AT C5-6 ON (B)(6) 2025. THIS IMPLANT WAS IDENTIFIED AS ONE OF THE LOT THAT WAS LABELED AS A 6MM HEIGHT BUT WAS ASSEMBLED AS A 5MM HEIGHT. THIS LOT IS UNDER A FSCA. AT THE (B)(6) 2025 FOLLOW-UP THE PATIENT REPORTED OVERALL IMPROVEMENT OF 80% AND STILL HAD SOME SPASMS AND MILD PAIN WITH EXTENSION. AT THE (B)(6) 2026 FOLLOW UP THE PATIENT REPORTED RIGHT HAND WEAKNESS AND SURGICAL SITE IRRITATION, THE PATIENT FELT LIKE THEY WERE REGRESSING. IMAGING FOUND THAT THE IMPLANT IS KYPHOTIC. SURGEON REPORTED THAT THE PATIENT HAS <1MM RANGE OF MOTION DUE TO THE KYPHOSIS. IF THE PATIENT'S SYMPTOMS DO NOT RESOLVE THE IMPLANT WILL BE REVISED.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 24318060 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A SIMPLIFY DEVICE AT C4-5. IT WAS FOUND THAT THE DEVICE HAD MIGRATED POSTERIORLY INTO THE CANAL RESULTING IN A DURAL TEAR AND A CSF LEAK. THE SURGEON REMOVED THE SIMPLIFY DEVICE AND REPLACED IT WITH A PRODISC C SK DEVICE ON (B)(6) 2025. THE PDC SK DEVICE DID NOT RESOLVE THE CSF LEAK SO THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23770906 ↗
• InjuryNov 12, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. PATIENT STATED THAT WHEN SHE AWOKE FROM IMPLANTATION SURGERY, SHE WAS PARALYZED WITH ONLY THE ABILITY TO MOVE HER EYES. PATIENT STATED THAT THE SURGEON TOLD HER THAT THE IMPLANT WAS PUSHED TOO FAR POSTERIOR, AND THAT THE IMPLANT HAD SMASHED HER SPINE, AND HE HAD TO TAKE IT OUT. PATIENT SPENT ONE WEEK IN THE ICU, FOLLOWED BY A MONTH AT A SPINE REHAB CENTER, PATIENT CONTINUES TO GO TO PT THREE TIMES A WEEK AND HAS BEEN UNABLE TO RETURN TO WORK. PATIENT HAD TO RELEARN HOW TO WALK AND CONTINUES TO HAVE ARM AND HAND NUMBNESS.

  Patient problems: Paralysis

  MAUDE report 23538309 ↗
• InjuryNov 12, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. PATIENT STATED THAT WHEN SHE AWOKE FROM IMPLANTATION SURGERY, SHE WAS PARALYZED WITH ONLY THE ABILITY TO MOVE HER EYES. PATIENT STATED THAT THE SURGEON TOLD HER THAT THE IMPLANT WAS PUSHED TOO FAR POSTERIOR, AND THAT THE IMPLANT HAD SMASHED HER SPINE, AND HE HAD TO TAKE IT OUT. PATIENT SPENT ONE WEEK IN THE ICU, FOLLOWED BY A MONTH AT A SPINE REHAB CENTER, PATIENT CONTINUES TO GO TO PT THREE TIMES A WEEK AND HAS BEEN UNABLE TO RETURN TO WORK. PATIENT HAD TO RELEARN HOW TO WALK AND CONTINUES TO HAVE ARM AND HAND NUMBNESS.

  Patient problems: Paralysis

  MAUDE report 23538306 ↗
• MalfunctionSep 18, 2025Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE AT C5-6 ON (B)(6) 2025. AT THE 2 WEEK FOLLOW UP, THE IMAGING SHOWED THAT THE IMPLANT MAY HAVE SLIGHTLY SUBSIDED AND KYPHOSED. THE PATIENT IS EXPERIENCING NO SYMPTOMS AND IS DOING WELL. THERE IS NO INDICATION AT PRESENT THAT ANY INTERVENTION WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084969 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WAS IMPLANTED WITH A PDC SK AT C5-6 AND A PDC VIVO AT C6-7 ON (B)(6) 2025. THE PATIENT WAS FOUND TO HAVE A NICKEL ALLERGY AND REQUIRED THE IMPLANTS TO BE REMOVED. THE IMPLANTS WERE BOTH REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED AT BOTH LEVELS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22725964 ↗
• InjuryFeb 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE AT C5-6 ON (B)(6) 2023. THE TDR LEVEL WAS REPORTED AS BEING HYPER MOBILE AND CAUSING PAIN, SURGEON STATED THAT THE PATIENT SEEMED TO NEVER QUITE HEAL AND THAT THE IMPLANT SEEMED LOOSE UPON REMOVAL. THE SURGEON REMOVED THE SK IMPLANT AND FUSED THE PATIENT ON (B)(6) 2025. SURGEON SENT THE PATIENT FOR SEROLOGICAL ALLERGY SCREENING POST REMOVAL AND FUSION TO RULE OUT ANY UNREPORTED METAL ALLERGIES AND THE RESULTS CONFIRMED THAT THE PATIENT HAS A PREVIOUSLY UNDIAGNOSED LOW GRADE NICKEL ALLERGY WHICH THE SURGEON BELIEVES CAUSED THE NEED TO EXPLANT THE SK.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21424076 ↗
• MalfunctionFeb 6, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 AND TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6)2024. IT WAS FOUND THAT THE VIVO IMPLANT HAD MIGRATED ANTERIORALLY, THE SK IMPLANT AT C5-6 WAS KYPHOTIC, AND THE SK IMPLANT AT C6-7 HAD MIGRATED POSTERIORLY AND SUBSIDED. A SECOND SURGEON RECOMMENDED REMOVING ALL THREE LEVELS AND FUSING C6-7 AND CONVERTING C4-5 AND C5-6 TO PDC ORIGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Spinal Column Injury

  MAUDE report 21327002 ↗
• MalfunctionFeb 6, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 AND TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024. IT WAS FOUND THAT THE VIVO IMPLANT HAD MIGRATED ANTERIORALLY, THE SK IMPLANT AT C5-6 WAS KYPHOTIC, AND THE SK IMPLANT AT C6-7 HAD MIGRATED POSTERIORALLY AND SUBSIDED. A SECOND SURGEON RECOMMENDED REMOVING ALL THREE LEVELS AND FUSING C6-7 AND CONVERTING C4-5 AND C5-6 TO PDC ORIGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Spinal Column Injury

  MAUDE report 21326996 ↗
• 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 ↗

Other Centinel Spine, LLC products

• Prodisc L16 models · 145 reports
• Prodisc C12 models · 35 reports · 1 recall
• Prodisc C Vivo10 models · 69 reports
• STALIF C3 models · 23 reports