Prodisc L PDL-L-PT10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00843193111708), received between Mar 23, 2021 and Jun 5, 2026 — classified as 10 injuries, 1 malfunction.

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 11 most recent of 11 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 25407544 ↗
• InjuryMay 8, 2026Migration or Expulsion of Device

  A PATIENT (47-YEAR-OLD, 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 25124409 ↗
• 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 23816317 ↗
• 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 23596604 ↗
• 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 23524379 ↗
• 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 21149474 ↗
• 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 18594862 ↗
• 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 18537055 ↗
• 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 12824036 ↗
• 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 12220980 ↗
• InjuryMar 23, 2021Fracture; Expulsion; Migration; Fracture; Expulsion; Migration

  A PATIENT WHO PREVIOUSLY SUFFERED A PRODISC L SUPERIOR ENDPLATE SUBLUXATION, PE INLAY EXPULSION, AND PE INLAY FRACTURE HAS UNDERGONE SURGICAL INTERVENTION. THE SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2021. THE PRODISC L CONSTRUCT WAS REMOVED AND REPLACED WITH A NEW PRODISC L CONSTRUCT USING A PDL-L-SP03 LARGE 3 DEG SUPERIOR ENDPLATE, PDL-L-PT10S LARGE 10MM PE INLAY, AND PDL-L-IP08S LARGE 8 DEG INFERIOR ENDPLATE. THERE WAS STILL NO INDICATION OF ANY PATIENT SYMPTOMS OR COMPLICATIONS BEYOND THE MALFUNCTION. THE PATIENT WAS CONSIDERED ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556509 ↗