ProDisc PDL-L-SP06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034700083), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT WAS ORIGINALLY IMPLANTED SOMETIME IN 2013 WITH A PRODISC-L (PDL) TOTAL DISC REPLACEMENT AT SPINE DISC LEVELS L4-L5. PATIENT WAS IMPLANTED WITH ONE (1) PDL CONSTRUCT. THE CONSTRUCT INCLUDED A SUPERIOR END PLATE LARGE, POLYETHYLENE INLAY LARGE AND INFERIOR END PLATE LARGE. ON AN UNKNOWN DATE POST-OPERATIVE, THE PATIENT PRESENTED WITH A PARS FRACTURE WHICH CAUSED THE PATIENT CONSISTENT PAIN. THE PARS FRACTURE WAS LOCATED BEHIND THE PDL L4-L5 IMPLANT. IT IS UNKNOWN WHAT CAUSED THE PARS FRACTURE. ON (B)(6) 2018, THE SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A COMPETITOR¿S ANTERIOR FUSION WITH CAGE. INTER-OPERATIVE, DUE TO PATIENT'S SCAR TISSUE, THE PDL SUPERIOR END PLATE PROVED DIFFICULT TO REMOVE. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. THE PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR A SUPERIOR END PLATE LARGE 6°-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 7593238 ↗