Prodisc L PDL-L-IP03SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843193114938), received between Jan 14, 2025 and Jun 5, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 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.

• InjuryJun 5, 2026Malposition of Device

  A PATIENT WAS IMPLANTED WITH TWO PRODISC L DEVICES AT L4-5 AND L5-S1 ON (B)(6) 2026. THE SURGEON IMPLANTED ONE OF THE DEVICES OFF OF MIDLINE BUT THOUGHT THAT IT WOULD BE OKAY. HOWEVER, THE PATIENT WAS EXPERIENCING LEG PAIN. THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.

  Patient problems: Limb Pain

  MAUDE report 25407545 ↗
• InjuryNov 11, 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 LEVEL L4-L5 AND L5-S1 ON (B)(6) 2024. THE PATIENT HAD COMPLAINTS OF ON-GOING PAIN AND REQUESTED THAT THE IMPLANTS BE REMOVED AND THAT THEY BE FUSED. REMOVAL WAS ATTEMPTED ON (B)(6) 2025, HOWEVER THE SURGEON COULD NOT VISUALIZE THE IMPLANT INTRAOPERATIVELY AND THE REMOVAL WAS NOT COMPLETED. NO STATUS UPDATE ON THE PATIENT WAS PROVIDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23524418 ↗
• InjuryNov 11, 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 LEVEL L4-L5 AND L5-S1 ON (B)(6) 2024. THE PATIENT HAD COMPLAINTS OF ON-GOING PAIN AND REQUESTED THAT THE IMPLANTS BE REMOVED AND THAT THEY BE FUSED. REMOVAL WAS ATTEMPTED ON (B)(6) 2025, HOWEVER THE SURGEON COULD NOT VISUALIZE THE IMPLANT INTRAOPERATIVELY AND THE REMOVAL WAS NOT COMPLETED. NO STATUS UPDATE ON THE PATIENT WAS PROVIDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23524383 ↗
• MalfunctionAug 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  A PATIENT WAS IMPLANTED WITH TWO PRODISC L IMPLANTS AT L4-5 AND L5-S1 ON (B)(6) 2025. AFTER IMPLANTATION X-RAY IMAGING SHOWED THAT THE IMPLANTS WERE NO LONGER IN THEIR ORIGINAL POSITIONS. PATIENT HAS NO SYMPTOMS AT THIS TIME, SO NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795782 ↗
• MalfunctionAug 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  A PATIENT WAS IMPLANTED WITH TWO PRODISC L IMPLANTS AT L4-5 AND L5-S1 ON (B)(6) 2025. AFTER IMPLANTATION X-RAY IMAGING SHOWED THAT THE IMPLANTS WERE NO LONGER IN THEIR ORIGINAL POSITIONS. PATIENT HAS NO SYMPTOMS AT THIS TIME, SO NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794308 ↗
• InjuryJan 14, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT AT L4/5 ON (B)(6) 2024, PDL WAS PLACED BELOW A FUSED LEVEL, THE FUSION WAS ALSO COMPLETED ON (B)(6) 2024. AFTER SURGERY IT WAS FOUND THAT THE IMPLANT WAS OFF OF MIDLINE 4-5MM LATERALLY. THE SURGEON REVISED THE PATIENT AND CORRECTED PLACEMENT OF THE IMPLANT IN A SECOND SURGERY ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149483 ↗