Prodisc L PDL-M-IP08SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00843193114976), received between Oct 2, 2024 and Mar 25, 2026 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Malposition of Device

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT L5-S1 ON (B)(6) 2026. THE PATIENT FELT TIPPED FORWARD AND IT WAS FOUND THAT THE DEVICE WAS KYPHOTIC. A REVISION WAS COMPLETED ON (B)(6) 2026 AND THE SUPERIOR ENDPLATE WAS REPOSITIONED A LITTLE DEEPER WHICH SEEMED TO CORRECT THE KYPHOSIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24690326 ↗
• InjuryJan 12, 2026Malposition of Device

  A PATIENT (FEMALE, 42 YEARS) WAS IMPLANTED WITH A PRODISC L DEVICE AT L5-S1 ON (B)(6) 2025. AFTER IMPLANTATION SURGERY THE PATIENT WAS EXPERIENCING NEUROLOGICAL ISSUES AND IT WAS FOUND THAT THE DEVICE WAS OFF OF MIDLINE BY 1.5 MM. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED WITH A CAGE AND PLATE.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24036141 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH TWO PRODISC L DEVICES AT L4-5 AND L5-S1 ON (B)(6) 2025. THE SURGERY WENT WELL AND WITHOUT CONCERN, THE PATIENT WAS FULLY DECOMPRESSED AT BOTH LEVELS AND IMPLANTS WERE WELL PLACED. THE PRE-OP PATIENT COMPLAINTS WERE RESOLVED BUT THE PATIENT PRESENTED 24 HOURS AFTER SURGERY WITH A NEW LEFT FOOT DROP. A POST-OP MRI WAS COMPLETED TO ASSESS THE CANAL AND THE ASSUMPTION THAT THE FOOT DROP IS A STRETCH INJURY OR A RETRACTOR INJURY. THE SURGEON TREATED THE PATIENT WITH STEROIDS AND THE PATIENT IS SLOWLY REGAINING SOME FUNCTION. SURGEON REQUESTED A PEER-TO-PEER DISCUSSION TO ENSURE THAT HE IS TREATING PROPERLY. DISCUSSION OUT OF THE PEER-TO-PEER MEETING RESULTED IN THE FOLLOWING CONCLUSIONS. THERE IS NO CONCERN WITH THE IMPLANT OR THE IMPLANT PLACEMENT. THIS IS AN UNCOMMON BUT POTENTIAL COMPLICATION FOR WHICH THERE ARE NO RELIABLE PRE-OPERATIVE TESTS OR INDICATORS. PATIENT WILL HAVE A CT MYELOGRAM DONE TO RULE OUT ANY COMPRESSION UNABLE TO BE IDENTIFIED WITH THE EXISTING POST OP MRI. PATIENT WILL CONTINUE MEDICATION AND THERAPY IN HOPES OF REGAINING FUNCTION IN THE FOOT.

  Patient problems: Movement Disorder

  MAUDE report 23008501 ↗
• InjuryJun 12, 2025Malposition of Device; Malposition of Device

  A PATIENT WAS IMPLANT WITH A PDL DEVICE AT L5-S1 ON (B)(6) 2025. FOLLOWING SURGERY, THE PATIENT HAD DEVELOPED LEG PAIN THAT WAS NOT PRESENT PRIOR TO SURGERY. IMAGING SHOWED THAT THE IMPLANT WAS TOO FAR FROM POSTERIOR. THE SURGEON REVISED THE IMPLANT ON (B)(6) 2025 BY REMOVING THE INLAY, REPOSITIONING THE ENDPLATES AND INSERTING A NEW INLAY.

  Patient problems: Limb Pain

  MAUDE report 22193244 ↗
• InjuryMar 3, 2025Expulsion; Expulsion

  PATIENT WAS IMPLANTED WITH A PDL IMPLANT AT L5-S1 ON (B)(6)2025. IMPLANT WAS REMOVED ON (B)(6)2025 AND THE PATIENT WAS FUSED. IMPLANT WAS REMOVED DUE TO IMPLANT EXPULSION, NO PATIENT SYMPTOMS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21510216 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT L5/S1 ON (B)(6) 2024. THE DEVICE WAS REMOVED ON (B)(6) 2024. NO REASON FOR REMOVAL WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20893992 ↗
• MalfunctionOct 2, 2024Collapse; Collapse

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE AT L5-S1 ON (B)(6) 2024. AT A FOLLOW UP APPOINTMENT IT WAS SUSPECTED THAT THE IMPLANT WAS SUBSIDED. ADDITIONAL IMAGING WAS REQUESTED TO BETTER VISUALIZE THE DEVICE. A CT SCAN WAS COMPLETED IT WAS CONFIRMED THAT THERE WAS A FRACTURED L5 ENDPLATE AND SOME SUBSIDENCE OF THE IMPLANT THERE. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND HAPPY WITH THE IMPLANT. THE SURGEON WILL FOLLOW THE PATIENT WITH ADDITIONAL RADIOGRAPHS EVERY 3-6 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350780 ↗