Prodisc L PDL-M-PT12SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193111777), received between Sep 1, 2021 and Mar 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH PRODISC L ON (B)(6) 2024 AT LEVEL L4-5. WITHIN 12 HOURS THE IMPLANT HAD SUBSIDED INTO THE VERTEBRAE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS REVISED TO AN ALIF ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18950148 ↗
• InjurySep 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT RECEIVED A PRODISC L MEDIUM 12MM IMPLANT ON (B)(6) 2021 WITHIN THE L5/S1 DISC SPACE. AFTER IMPLANTATION ON (B)(6) 2021, FOLLOW UP IMAGING INDICATED THE SUPERIOR ENDPLATE SUBSIDED INTO THE L5 VERTEBRAE. THE PATIENT WAS NOT REPORTING ANY COMPLICATIONS OR SYMPTOMS. THE SURGEON CHOSE TO PERFORM A REVISION/SECOND SURGERY TO ADD POSTERIOR MIS PEDICLE SCREWS ACROSS L5/S1. THE SECOND SURGERY WAS PERFORMED ON (B)(6) 2021 TO CONTROL THE SUBSIDENCE. THE PRODISC L IMPLANT WAS LEFT IMPLANTED. THERE WAS NO OTHER PATIENT COMORBIDITIES.

  Patient problems: Spinal Column Injury

  MAUDE report 12407455 ↗