Prodisc L PDL-L-SP11SRecalls & reported problems
Centinel Spine, LLC · SUPERIOR END PLATE LARGE 11°-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 00843193111746), received between Mar 18, 2020 and Mar 23, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Expulsion” (1 report).
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.
Most reported problems
Device problems
- Expulsion1
- Fracture1
- Migration1
- Migration or Expulsion of Device1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2021Fracture; Expulsion; Migration; Fracture; Expulsion; Migration
A PATIENT WHO PREVIOUSLY SUFFERED A PRODISC L SUPERIOR ENDPLATE SUBLUXATION, PE INLAY EXPULSION, AND PE INLAY FRACTURE HAS UNDERGONE SURGICAL INTERVENTION. THE SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2021. THE PRODISC L CONSTRUCT WAS REMOVED AND REPLACED WITH A NEW PRODISC L CONSTRUCT USING A PDL-L-SP03 LARGE 3 DEG SUPERIOR ENDPLATE, PDL-L-PT10S LARGE 10MM PE INLAY, AND PDL-L-IP08S LARGE 8 DEG INFERIOR ENDPLATE. THERE WAS STILL NO INDICATION OF ANY PATIENT SYMPTOMS OR COMPLICATIONS BEYOND THE MALFUNCTION. THE PATIENT WAS CONSIDERED ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11556500 ↗InjuryMar 18, 2020Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement
PATIENT WAS REPORTED TO HAVE LOW BACK PAIN WHICH WAS CAUSED OR CONTRIBUTED TO BY THE PATIENT'S PRODISC L US IMPLANT. IMAGING OF THE PRODISC L DEVICE FOUND THE PRODISC L PE INLAY HAD EXPELLED FROM THE INFERIOR ENDPLATE. SURGICAL INTERVENTION TO REMOVE THE PRODISC L IMPLANT WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS CONVERTED TO A FUSION VIA UNKNOWN DEVICE FROM L4 THROUGH S1. THE PRODISC L DEVICE WAS IMPLANTED AT L5-S1.
Patient problems: Osteopenia/ Osteoporosis; Pain
MAUDE report 9849292 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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