ProDisc PDL-M-SP11SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034700182), received between May 2, 2018 and May 14, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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 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.

• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171582 ↗
• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171495 ↗
• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171494 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT AT L5-S1 ON (B)(6) 2019. PATIENT EXPERIENCED INSTABILITY AT THE LEVEL DUE TO A BILATERAL PARS FRACTURE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED ON (B)(6) 2025.

  Patient problems: Bone Fracture(s)

  MAUDE report 21273771 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PRODISC-L REMOVAL AT L5-S1 ON (B)(6) 2018, DUE TO PAIN. THE PATIENT WAS IMPLANTED WITH THE PRODISC-L ON AN UNKNOWN DATE APPROXIMATELY ONE (1) YEAR AGO AND THE ADJACENT LEVELS ARE FUSED WITH NON-SYNTHES DEVICES. NO OTHER LEVELS WERE OPERATED ON. THIS WAS NOT AN ADJACENT LEVEL CASE. THE REMOVAL WENT SMOOTHLY AND THE PRODISC APPEARED TO BE IN GOOD CONDITION AND FUNCTIONING AS INTENDED. IT WAS REMOVED EASILY AND A FUSION DEVICE WAS SUCCESSFULLY IMPLANTED. THE REVISION WAS DUE TO THE PATIENT'S CONTINUED BACK PAIN WHICH THE SURGEON BELIEVED WOULD BE RESOLVED THROUGH A FUSION. NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN FUSION HARDWARE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN).

  Patient problems: No Code Available; Pain

  MAUDE report 7481874 ↗