ProDisc PDL-M-PT10SRecalls & reported problems
Synthes (U.S.A.) LP · POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE · Class 3 · Implant
All models of ProDisc (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034700137), received between Feb 6, 2013 and Jan 30, 2025 — classified as 3 injuries.
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 Problem3
Patient problems
- Pain2
- Bone Fracture(s)1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT AT L5-S1 ON (B)(6) 2019. PATIENT EXPERIENCED INSTABILITY AT THE LEVEL DUE TO A BILATERAL PARS FRACTURE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED ON (B)(6) 2025.
Patient problems: Bone Fracture(s)
MAUDE report 21273785 ↗InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE IS A PRODISC-L REMOVAL SCHEDULED FOR (B)(6) 2018. THE CASE IS TO ADDRESS A PRODISC-L REMOVAL AT L5-S1 WITH THE PRIMARY GOAL OF REPLACING THE IMPLANT WITH A FUSION DEVICE. THE ADJACENT LEVELS ARE FUSED WITH NON-SYNTHES DEVICES. NO OTHER LEVELS ARE TO BE OPERATED ON. THIS IS NOT AN ADJACENT LEVEL CASE. THE EXACT REASON FOR REMOVAL IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN FUSION HARDWARE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).
Patient problems: No Code Available; Pain
MAUDE report 7481868 ↗InjuryFeb 6, 2013Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: Pain; Unspecified Infection
MAUDE report 2945052 ↗
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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