Prodisc CRecalls & reported problems across all models
Centinel Spine, LLC · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 1
We found 12 models of Prodisc C by Centinel Spine, LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2020 and Jun 25, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Migration” (6 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Reports received per month, all models
Prodisc C 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.
- 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 Prodisc C problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Migration6
- Inadequacy of Device Shape and/or Size4
- Insufficient Device Problem Information3
- Migration or Expulsion of Device3
- Biocompatibility2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Malposition of Device2
Patient problems
- Neck Pain15
- Pain11
- No Clinical Signs, Symptoms or Conditions5
- Vertebral Fracture3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Dysphagia/ Odynophagia2
- Extraskeletal ossification2
- Hypersensitivity/Allergic reaction2
Prodisc C models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prodisc C 09.820.055SProsthesis, Intervertebral Disc1 recall9 reports
- Prodisc C 09.820.026SProsthesis, Intervertebral Disc5 reports
- Prodisc C 09.820.036SProsthesis, Intervertebral Disc5 reports
- Prodisc C 09.820.045SProsthesis, Intervertebral Disc5 reports
- Prodisc C 09.820.035SProsthesis, Intervertebral Disc3 reports
- Prodisc C 09.820.056SProsthesis, Intervertebral Disc2 reports
- Prodisc C 09.820.046SProsthesis, Intervertebral Disc1 report
- Prodisc C 09.820.047SProsthesis, Intervertebral Disc1 report
- Prodisc C 09.820.066SProsthesis, Intervertebral Disc1 report
- Prodisc C 09.820.075SProsthesis, Intervertebral Disc1 report
- Prodisc C 09.820.076SProsthesis, Intervertebral Disc1 report
- Prodisc C 09.820.077SProsthesis, Intervertebral Disc1 report
Recent Prodisc C adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryApr 1, 2026Migration
A PATIENT (51 YO, FEMALE) WAS IMPLANTED WITH A PRODISC C DEVICE AT C4-5 ON (B)(6) 2025. PATIENT HAS A FRACTURE OF C5, LEFT SIDE WORSE THAN RIGHT, CAUSING SCOLIOSIS. THERE IS GROSS INSTABILITY AND MIGRATION OF THE IMPLANT SEEN UPON FLEX-EX IMAGING. C5-7 IS KYPHOTIC AND LARGE ANTERIOR OSTEOPHYTES AT C6-7. PATIENT HAS ONGOING PAIN. A REMOVAL WAS COMPLETED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.
Patient problems: Pain; Vertebral Fracture
MAUDE report 24752752 ↗InjuryFeb 24, 2026Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth
A PATIENT (58YO, FEMALE) WAS IMPLANTED WITH A PDC DEVICE AT C6-7 ON (B)(6) 2025. PATIENT HAD PREVIOUSLY HAD AN ACDF AT LEVEL C5-6, COMPLETED IN 2005. PATIENT HAD INITIAL SYMPTOM RELIEF BUT THEN WAS EXPERIENCING WORSENING PAIN. IT WAS FOUND THAT THE PATIENT HAD A C7 FRAGILITY FRACTURE, AND PDC DEVICE SUBSIDENCE WITH KYPHOSIS AND ANTERIOR MIGRATION. THE PDC DEVICE WAS REMOVED ON (B)(6) 2026 AND THE PATIENT AN ACDF PEEK INTERBODY WITH PLATE AND SCREWS.
Patient problems: Pain
MAUDE report 24432491 ↗InjuryJan 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
A PATIENT WAS IMPLANTED WITH A PRODISC C IMPLANT AT C5-6 ON (B)(6) 2023. IT WAS LATER FOUND THAT THE IMPLANT HAD COLLAPSED ON THE LEFT SIDE AND WAS CAUSING RECURRENT LEFT C5-6 FORAMINAL STENOSIS. THE IMPLANT WAS REMOVED ON (B)(6) 2024 AND THE PATIENT WAS FUSED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21152398 ↗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 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6 ON (B)(6) 2021. PATIENT BEGAN EXPERIENCING RADICULAR SYMPTOMS AND THE IMPLANT WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS CONVERTED TO A TWO LEVEL ACDF.
Patient problems: Pain
MAUDE report 20076465 ↗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, 2023Migration; Migration
PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C4-5 ON (B)(6) 2023. PATIENT HAD LINGERING RADICULAR SYMPTOMS BUT DEVELOPED AN URGENT SWALLOWING ISSUE AT 7 MONTHS POST OP. IT WAS DETERMINED THAT THE IMPLANT MIGRATED TO A 90% EGRESS OF THE ADR. PATIENT WAS REVISED TO AN ACDF ON 02NOV2023.
Patient problems: Dysphagia/ Odynophagia; Neck Pain
MAUDE report 18237628 ↗InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT RECEIVED A PRODISC C IMPLANT AT LEVEL C3-4 ON (B)(6) 2023. DUE TO THE PATIENT'S POOR BONE QUALITY THE SURGEON REMOVED THE PDC IMPLANT ON (B)(6) 2023 AND PERFORMED A CORPECTOMY AT THE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182433 ↗InjuryAug 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C6-C7 ON (B)(6) 2021. THE IMPLANT WAS REMOVED ON (B)(6) 2023. NO INFORMATION OR IMAGING WAS PROVIDED TO DETAIL THE PATIENT'S CONDITION OR REASON FOR THE REMOVAL. THE IMPLANT WAS REPLACED WITH A FUSION DEVICE.
Patient problems: Insufficient Information
MAUDE report 17461045 ↗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 ↗InjuryMay 3, 2023Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device
IT WAS REPORTED THAT A PATIENT RECEIVED A PRODISC C IMPLANT ON (B)(6) 2022. THE PATIENT EXPERIENCED INCREASED NECK AND ARM PAIN AND AN X-RAY FOUND THAT THERE WAS A CHANGE IN IMPLANT POSITION RESULTING IN KYPHOSIS AND FISH MOUTHING OF THE IMPLANT. A PRODISC C REMOVAL WAS COMPLETED ON (B)(6) 2023. PATIENT WAS REVISED BY A CORELINK 3D PRINTED TITANIUM CAGE.
Patient problems: Neck Pain
MAUDE report 16859741 ↗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 ↗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 15819192 ↗InjuryMar 25, 2022Biocompatibility; Biocompatibility
ON (B)(6) 2022 THE SURGEON SCHEDULED A 2 LEVEL PDC, ADJACENT LEVELS ABOVE AND BELOW A PREVIOUS FUSION OF C5-7. THE PATIENT HAD AN EXISTING PLATE AND CORPECTOMY CAGE (ALL TITANIUM ALLOY IMPLANTS). BEFORE STARTING THE CASE, THE SURGEON ASKED WHAT THE NICKEL CONTENT IS IN THE PRODISC C. A LETTER STATING 0.18% IN CO-28CR-6MO COBALT CHROMIUM WAS PROVIDED TO THE SURGEON. THE PATIENT HAD A POSSIBLE NICKEL ALLERGY, BUT SAID IT WAS MOSTLY A SKIN REACTION TO SOME JEWELRY. SURGEON IMPLANTED 2 PRODISC C IMPLANTS PER SCHEDULED PROCEDURE. TWO WEEKS POST OP, THE PATIENT HAS BEEN COMPLAINING AND TREATED FOR FACE NECK AND UPPER CHEST RASHES AND IRRITATION. PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS AS IT THOUGHT IT MAY BE A POSSIBLE SURGICAL SITE INFECTION. SINCE FINISHING THE COURSE OF MEDICATION, THE IRRITATION, RASH AND NOW SWELLING AROUND THE EYES HAS WORSENED. PATIENT HAD ALL NECK AND ARM PAIN AND ISSUES RESOLVED COMPLETELY WITH THE 2 LEVEL PRODISC C. PATIENT IS DOING VERY WELL FROM THAT ASPECT. NO INDICATION OF SURGICAL INTERVENTION.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 13906428 ↗
Other Centinel Spine, LLC products
All Centinel Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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