ProDisc PDL-M-SP06SRecalls & reported problems
Synthes (U.S.A.) LP · SUPERIOR END PLATE MEDIUM 6°-STERILE · Class 3 · Implant
All models of ProDisc (9)
Data updated Oct 16, 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 10705034700175), received between Feb 5, 2013 and Oct 3, 2023 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
Patient problems
- Insufficient Information1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2023Expulsion; Expulsion
PATIENT RECEIVED A PRODISC L DEVICE ON (B)(6) 2009 DUE TO DEGENERATIVE DISC DISEASE AT L4-5. IT WAS FOUND THAT THE POLY HAD DISPLACED ANTERIORLY. THE PDL WAS REMOVED ON (B)(6) 2023 AND THE PATIENT CONVERTED TO AN ALIF. PRE-REMOVAL IMAGING WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17865588 ↗InjuryFeb 5, 2013Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: Pain; Unspecified Infection
MAUDE report 2944844 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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