Prodisc L PDL-L-SP06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843193111739), received between Jan 28, 2020 and Apr 20, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 reports).

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.

• InjuryApr 20, 2026Osseointegration Problem

  A MALE PATIENT WITH DISEASE OF THE SPINAL CORD AND SECONDARY SCOLIOSIS WAS IMPLANTED WITH PRODISC DISCS AT MULTIPLE LEVELS IN SEVERAL SURGERIES. IMPLANTATION INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISC AT L5-S1 WAS PREVIOUSLY REMOVED AND CONVERTED TO FUSION WHICH FAILED, ADDITIONALLY THE L4-5 POSTERIOR FUSION FAILED. THE PATIENT WAS EXPERIENCING NEUROLOGICAL SYMPTOMS AND PAIN. DUE TO POOR BONE QUALITY, ADEQUATE FIXATION OF THE PRODISC L DEVICES AT LEVELS L2-3 AND L3-4 WAS NOT ACHIEVED. ON (B)(6) 2026 THE IMPLANTS AT THOSE LEVELS WERE REMOVED AND REPLACED WITH ALIF CAGES.

  Patient problems: Neuropathy; Pain

  MAUDE report 24931570 ↗
• InjuryFeb 15, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON (B)(6) 2023, A SURGEON IMPLANTED THE PATIENT WITH TWO PRODISC L DEVICES. AT TWO WEEKS POST-OP, THE PATIENT WAS EXPERIENCING RADICULAR SYMPTOMS AND PAIN. IT WAS FOUND THAT ONE LEVEL HAD SUBSIDED AND ONE LEVEL HAD MIGRATED. AT FOLLOW UP, PATIENT IS ASYMPTOMATIC AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION HAS BEEN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713589 ↗
• InjuryFeb 15, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON (B)(6) 2023, A SURGEON IMPLANTED THE PATIENT WITH TWO PRODISC L DEVICES. AT TWO WEEKS POST-OP, THE PATIENT WAS EXPERIENCING RADICULAR SYMPTOMS AND PAIN. IT WAS FOUND THAT ONE LEVEL HAD SUBSIDED AND ONE LEVEL HAD MIGRATED. AT FOLLOW UP, PATIENT IS ASYMPTOMATIC AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION HAS BEEN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713506 ↗
• InjuryNov 16, 2021Expulsion; Migration; Expulsion; Migration

  A PATIENT RECEIVED A PRODISC L IMPLANT AT L5-S1 ON (B)(6) 2021. DURING IMPLANTATION, THE SURGEON HAD DIFFICULTY SEATING THE PE INLAY INTO THE INFERIOR ENDPLATE. THIS CHALLENGE WAS OVERCOME AND THE PATIENT'S IMPLANTATION WAS COMPLETED WITHOUT PATIENT HARM. ON AN UNKNOWN DATE AT A 6 MONTH FOLLOW UP EXAM, THE PATIENT'S X-RAYS REVEALED THE PE INLAY HAD EXPELLED FROM THE INFERIOR ENDPLATE AND THE SUPERIOR ENDPLATE MIGRATED ANTERIORLY OUT OF THE DISC SPACE. THE PATIENT WAS NOT EXPERIENCING ANY COMPLICATIONS OR SYMPTOMS. THE PATIENT WAS SCHEDULED FOR REMOVAL. ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF THE PRODISC L DEVICES. THE DEVICES WERE REPLACED WITH ANOTHER ARTIFICIAL DISC FROM AN UNKNOWN MANUFACTURER. THE DEVICE WAS SELECTED BASED ON DESIGN WITHOUT A KEEL. REVISION WAS COMPLETED WITHOUT ISSUE. PATIENT STATUS POST-OP IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823927 ↗
• MalfunctionJul 23, 2021Migration; Migration

  A PATIENT RECEIVED A PDL US IMPLANT ON (B)(6) 2021. THE PATIENT HAS NOW SUFFERED A DEVICE MIGRATION WHICH IS CONTRIBUTING TO BACK PAIN. THIS TYPE OF MALFUNCTION IS LIKELY TO LEAD TO SURGICAL INTERVENTION TO CORRECT THE PROBLEM AND PREVENT SERIOUS INJURY. THE PATIENT HAS NOT BEEN SCHEDULED FOR SURGICAL INTERVENTION AS OF THIS SUBMISSION.

  Patient problems: Pain

  MAUDE report 12221035 ↗
• InjuryJan 28, 2020Migration; Migration

  PATIENT UNDERWENT REVISION SURGERY TO REMOVE A PRODISC L CONSTRUCT FROM THE L5-S1 DISC SPACE. THE PATIENT EXPERIENCED A "POP" SENSATION DUE TO UNKNOWN CIRCUMSTANCES POST OPERATIVELY. THE PATIENT WAS EXPERIENCING PAIN WHEN LYING DOWN. THE SURGEON DISCOVERED VIA X-RAY THAT THE PATIENT SUFFERED A PEDICLE FRACTURE, AND THE PRODISC L INFERIOR ENDPLATE HAD MIGRATED ANTERIORLY. THE SURGEON DETERMINED MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE PRODISC L CONSTRUCT AND REPLACE IT WITH AN ALIF USING MIDLINE II-TI CAGE AND MIDLINE ABO SCREWS.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9638546 ↗