Prodisc L PDL-L-IP00SRecalls & reported problems
Centinel Spine, LLC · INFERIOR END PLATE LARGE-STERILE · Class 3 · Implant
All models of Prodisc L (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193111692), received between Apr 20, 2026 and Apr 20, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem2
Patient problems
- Neuropathy2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Osseointegration Problem
A MALE PATIENT WITH DISEASE OF THE SPINAL CORD AND SECONDARY SCOLIOSIS WAS IMPLANTED WITH PRODISC DISCS AT MULTIPLE LEVELS IN SEVERAL SURGERIES. IMPLANTATION INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISC AT L5-S1 WAS PREVIOUSLY REMOVED AND CONVERTED TO FUSION WHICH FAILED, ADDITIONALLY THE L4-5 POSTERIOR FUSION FAILED. THE PATIENT WAS EXPERIENCING NEUROLOGICAL SYMPTOMS AND PAIN. DUE TO POOR BONE QUALITY, ADEQUATE FIXATION OF THE PRODISC L DEVICES AT LEVELS L2-3 AND L3-4 WAS NOT ACHIEVED. ON (B)(6) 2026 THE IMPLANTS AT THOSE LEVELS WERE REMOVED AND REPLACED WITH ALIF CAGES.
Patient problems: Neuropathy; Pain
MAUDE report 24931189 ↗InjuryApr 20, 2026Osseointegration Problem
A MALE PATIENT WITH DISEASE OF THE SPINAL CORD AND SECONDARY SCOLIOSIS WAS IMPLANTED WITH PRODISC DISCS AT MULTIPLE LEVELS IN SEVERAL SURGERIES. IMPLANTATION INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISC AT L5-S1 WAS PREVIOUSLY REMOVED AND CONVERTED TO FUSION WHICH FAILED, ADDITIONALLY THE L4-5 POSTERIOR FUSION FAILED. THE PATIENT WAS EXPERIENCING NEUROLOGICAL SYMPTOMS AND PAIN. DUE TO POOR BONE QUALITY, ADEQUATE FIXATION OF THE PRODISC L DEVICES AT LEVELS L2-3 AND L3-4 WAS NOT ACHIEVED. ON (B)(6) 2026 THE IMPLANTS AT THOSE LEVELS WERE REMOVED AND REPLACED WITH ALIF CAGES.
Patient problems: Neuropathy; Pain
MAUDE report 24931182 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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