Prodisc L PDL-M-SP06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843193111791), received between Sep 18, 2020 and Nov 18, 2025 — classified as 5 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH TWO PRODISC L DEVICES AT L4/5 AND L5/S1 ON (B)(6) 2025. AFTER THE IMPLANTATION SURGERY, THE PATIENT WAS HAVING NERVE PAIN AND IT WAS FOUND THAT THE POSTERIOR ASPECT OF THE SUPERIOR VERTEBRAL BODY BROKE OFF AND DISLODGED AT THE L5/S1 LEVEL. ON (B)(6) 2025 THE SURGEON REMOVED THE IMPLANT, REPLACED IT WITH AN ANTERIOR LUMBAR CAGE AS WELL AS COMPLETED POSTERIOR DECOMPRESSION AND SCREW FIXATION AT THAT LEVEL.

  Patient problems: Bone Fracture(s)

  MAUDE report 23584538 ↗
• InjuryJan 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) 2024. THE PATIENT HAD ON-GOING PAIN WITH NO MALFUNCTION OF THE DEVICE. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21167800 ↗
• InjuryMar 17, 2022Expulsion; Expulsion

  A PATIENT RECEIVED A 2-LEVEL PRODISC L CONSTRUCT AT L4/5 AND L5/S1 ON (B)(6) 2020. THE PATIENT HAD A LIFTING EPISODE AT THE ONSET OF SYMPTOMS APPROXIMATELY 1 YEAR POST-OP. THE PATIENT X-RAY IMAGING SHOWED BILATERAL PEDICLE FRACTURES OF L4 AND L5 AS WELL AS INLAY EXPULSION OF THE L5/S1 PRODISC L IMPLANT. PEER TO PEER REVIEW OF THE PATIENT SUGGESTED THERE WAS NO SPACE BETWEEN THE FACETS OF THE INVOLVED VERTEBRAE WHICH PLACED STRESS ALONG THE PEDICLES. A HEAVY LIFTING ACTIVITY COULD HAVE CREATED THE FORCE TO CAUSE THE BILATERAL FRACTURES. IN (B)(6) 2022 THE PATIENT UNDERWENT REVISION BY A DIFFERENT UNKNOWN SURGEON TO REMOVE THE PRODISC L IMPLANT FROM L5/S1 AND REPLACE IT WITH AN UNKNOWN FUSION CAGE WITH INTEGRATED FIXATION. THE PATIENT ALSO RECEIVED POSTERIOR FIXATION FROM L4 TO S2.

  Patient problems: Vertebral Fracture

  MAUDE report 13792274 ↗
• 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 12407412 ↗
• InjurySep 18, 2020Migration; Migration

  A PATIENT UNDERWENT A PRODISC L REMOVAL SURGERY DUE TO ANTERIOR MIGRATION OF THE IMPLANT. THE SURGEON REMOVED THE IMPLANT DUE TO THE LOSS OF FIXATION AND CONCERNS OF BLOOD VESSEL ADHESION TO THE PRODISC L IMPLANT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion

  MAUDE report 10557095 ↗