Prodisc L PDL-L-SP03SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843193114952), received between Jan 18, 2024 and Jun 5, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 13 most recent of 13 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 25407543 ↗
• 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 25124502 ↗
• 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 24931172 ↗
• 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 23816316 ↗
• 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 (B)(6) 2025 AND THE PATIENT WAS FUSED WITH AN ALIF PROCEDURE.

  Patient problems: Pain

  MAUDE report 23596611 ↗
• 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 23524385 ↗
• 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 23524380 ↗
• 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 22794280 ↗
• 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 22794279 ↗
• 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 21149469 ↗
• 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 20693941 ↗
• 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 18594877 ↗
• 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 18536532 ↗