Prodisc L PDL-L-IP08SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843193114945), received between Jan 18, 2024 and May 8, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Migration or Expulsion of Device

  A PATIENT (47YO, MALE) WAS IMPLANTED WITH A PRODISC L IMPLANT AT LEVEL L5-S1 ON (B)(6) 2025. THE PATIENT PRESENTED TO THE CLINIC FOR THEIR 6 MONTH FOLLOW UP AND IMAGING WAS COMPLETED. ALTHOUGH NO ACUTE INJURY OCCURRED AND PATIENT IS ASYMPTOMATIC, THE IMAGINING SHOWED THAT THE IMPLANT HAD EXPULSED FROM THE VERTEBRAL BODIES. A REMOVAL HAS BEEN SCHEDULED FOR (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124246 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT L5-S1 ON (B)(6) 2025. PATIENT BECAME SYMPTOMATIC AND AT A FOLLOW UP IT WAS FOUND THAT THE PATIENT PRESENTED WITH AN L5 PEDICLE FRACTURE. THE SURGEON REQUESTED A PEER-TO-PEER EVALUATION AND THE DECISION WAS MADE TO BRACE THE PATIENT TO ALLOW THE FRACTURE TO HEAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 23816307 ↗
• InjuryNov 19, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT L5-S1 ON (B)(6) 2025. THE PATIENT HAD RADIATING LEG PAIN AND IT WAS FOUND THAT THE IMPLANT WAS POORLY PLACED. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED WITH AN ALIF PROCEDURE.

  Patient problems: Pain

  MAUDE report 23596613 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE. IT WAS SUSPECTED THAT THE PATIENT HAD A PARS FRACTURE. THE IMPLANT WAS REMOVED AND THE PATIENT FUSED ON (B)(6) 2024.

  Patient problems: Bone Fracture(s)

  MAUDE report 20693968 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PRODISC L REVISION WAS COMPLETED ON (B)(6) 2024. THE SURGEON MADE THE DECISION TO ADD POSTERIOR SCREWS AT THE PDL LEVEL.

  Patient problems: Spinal Column Injury

  MAUDE report 18594856 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT THE L5/S1 LEVEL ON (B)(6) 2023. FOLLOWING THE IMPLANTATION SURGERY, THE PATIENT WAS FOUND TO HAVE BILATERAL PARS FRACTURES AT THE INDEX LEVEL. THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. THE SURGEON HAS DETERMINED THAT THE PATIENT WILL WEAR A BRACE AND BE RE-EVALUATED IN FOUR MONTHS TIME.

  Patient problems: Multiple Fractures

  MAUDE report 18536524 ↗