Prodisc L PDL-M-IP03SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843193114969), received between Mar 24, 2022 and Dec 18, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 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. THE PATIENT WAS EXPERIENCING WEAKNESS IN THE LEFT FOOT AND CALF FOLLOWING THE PDL IMPLANTATION. THE SURGEON BELIEVED THAT DURING IMPLANTATION OF THE PDL, THE KEEL CUT DISLODGED SOME BONY FRAGMENTS CAUSING THE PATIENT'S SYMPTOMS. ON (B)(6) 2025 THE SURGEON COMPLETED A REVISION SURGERY WHERE HE REMOVED BONE FRAGMENTS AND THEN FUSED THE PATIENT VIA A POSTERIOR APPROACH USING PEDICLE SCREWS AND RODS.

  Patient problems: Neuropathy

  MAUDE report 23837912 ↗
• InjuryNov 18, 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 L4/5 AND L5/S1 ON (B)(6) 2025. AFTER THE IMPLANTATION SURGERY, THE PATIENT WAS HAVING NERVE PAIN AND IT WAS FOUND THAT THE POSTERIOR ASPECT OF THE SUPERIOR VERTEBRAL BODY BROKE OFF AND DISLODGED AT THE L5/S1 LEVEL. ON (B)(6) 2025 THE SURGEON REMOVED THE IMPLANT, REPLACED IT WITH AN ANTERIOR LUMBAR CAGE AS WELL AS COMPLETED POSTERIOR DECOMPRESSION AND SCREW FIXATION AT THAT LEVEL.

  Patient problems: Bone Fracture(s)

  MAUDE report 23584539 ↗
• InjuryOct 31, 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) 2025. IT WAS FOUND AT A FOLLOW UP APPOINTMENT THAT THE PATIENT HAD BILATERAL PARS FRACTURES AT THE IMPLANT LEVEL. PATIENT IS BEING MONITORED AND NO SURGICAL INTERVENTION HAS BEEN SCHEDULED AT THIS TIME.

  Patient problems: Multiple Fractures

  MAUDE report 23436084 ↗
• 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 23008499 ↗
• InjuryJan 24, 2025Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH TWO PDL DEVICES ON (B)(6) 2024 AT L4/5 AND L5/S1, THE DEVICE AT L4/5 SUBSIDED LESS THAN A WEEK LATER CAUSING BACK PAIN. THE SURGEON THEN REMOVED BOTH DEVICES AND FUSED THE PATIENT ON (B)(6) 2024.

  Patient problems: Implant Pain

  MAUDE report 21230154 ↗
• InjuryJan 24, 2025Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH TWO PDL DEVICES ON (B)(6) 2024 AT L4/5 AND L5/S1, THE DEVICE AT L4/5 SUBSIDED LESS THAN A WEEK LATER CAUSING BACK PAIN. THE SURGEON THEN REMOVED BOTH DEVICES AND FUSED THE PATIENT ON (B)(6) 2024.

  Patient problems: Implant Pain

  MAUDE report 21230127 ↗
• InjuryJan 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) 2024. THE PATIENT HAD ON-GOING PAIN WITH NO MALFUNCTION OF THE DEVICE. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21167807 ↗
• InjuryMay 28, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS IMPLANTED WITH A PRODISC L AT LEVEL L4-5 ON (B)(6) 2024. THE PATIENT HAD DIFFICULT ANATOMY AND THE IMPLANT WAS UNDERSIZED, ADDITIONALLY A TDR AT LEVEL L5-S1 WAS SKIPPED DUE TO THE ANATOMY. APPROXIMATELY A MONTH AND A HALF AFTER IMPLANTATION THE PATIENT EXPERIENCED A TRAUMATIC FALL AND THIS CAUSED THE INFERIOR ENDPLATE TO SUBSIDE INTO THE INFERIOR VERTEBRAL BODY. PATIENT IS HAVING NEW LEG PAIN SINCE THE FALL OCCURRED. SURGEON PLANS TO REVISE THE PATIENT AND ADD POSTERIOR FUSION AT L4-5 AND L5-S1. THE DATE OF REVISION WAS NOT PROVIDED.

  Patient problems: Limb Pain

  MAUDE report 19404473 ↗
• InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH PRODISC L ON (B)(6) 2024 AT LEVEL L4-5. WITHIN 12 HOURS THE IMPLANT HAD SUBSIDED INTO THE VERTEBRAE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS REVISED TO AN ALIF ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18950163 ↗
• InjuryJul 24, 2023Migration; Migration

  THE PATIENT WAS IMPLANTED WITH THE PRODISC L DEVICE ON (B)(6) 2023 AT THE L5/S1 LEVEL DUE TO A PRIMARY DIAGNOSIS OF LUMBAR DEGENERATIVE JOINT DISEASE. THE IMPLANT WAS REMOVED ON (B)(6) 2023. THE REASON FOR THE REMOVAL WAS POSTERIOR MIGRATION OF THE IMPLANT. THE REMOVAL SURGERY WENT SMOOTHLY AND WITHOUT ISSUE. NO FURTHER INFORMATION OR IMAGING WAS PROVIDED BY THE DISTRIBUTOR OR SURGEON. THE PATIENT WAS FUSED USING AN UNKNOWN DEVICE AT THE L5/S1 LEVEL AFTER THE PRODISC L DEVICE WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17376056 ↗
• InjuryMay 2, 2023Improper or Incorrect Procedure or Method; Malposition of Device; Improper or Incorrect Procedure or Method; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PDL IMPLANT AT L5/S1 IN LOUISIANA A FEW MONTHS AGO AND PRESENTED WITH SIGNIFICANT PAIN. SURGEON BELIEVES THAT SHE CAN BE REVISED TO ANOTHER PDL. REMOVAL SURGERY WAS COMPLETED ON (B)(6)2023.

  Patient problems: Pain

  MAUDE report 16855489 ↗
• InjuryMar 24, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A PATIENT IS 1 WEEK POST OF COMPLAINING OF SCIATIC PAIN AS WELL AS NUMBNESS AND WEAKNESS IN THE BIG TOE. THE PATIENT RECEIVED PRODISC L IMPLANTS IN L4/5 AND L5/S1 ON (B)(6) 2022. DURING THE PROCEDURE, NEURAL MONITORING SHOWED EMG CHANGES WHILE TRIALING. 10-MIN AFTER DEVICE IMPLANTATION, THE L5 NERVE WENT DOWN. ANOTHER 5 MIN LATER, IT WAS FINE AGAIN. IN RECOVERY THE L5 NERVE WAS EXHIBITING CALF PAIN, BIG TOE WEAKNESS, BUT NO SCIATIC PAIN. BACK PAIN WAS IMPROVED. THE PATIENT HAD WEAK DORSIFLEXION OF THE LEFT ANKLE BUT LEFT WITHOUT AN ANKLE FOOT ORTHOSIS. PATIENT IS NOW DEVELOPING SCIATIC PAIN IN BUTTOCK AND DOWN TO CALF. NUMBNESS AND WEAKNESS IN BIG TOE. CONSULTING SURGEON SUGGESTED RADICULAR GRAM AND CT SCAN WITH DYE TO TRY TO UNDERSTAND WHY FACETS AT L5 ARE ASYMMETRICAL AND NERVE RELEASE BY POSTERIOR APPROACH DUE THE NERVE NOT HAVING ENOUGH SPACE. CHANGES IN NEURAL MONITORING SUGGESTS THAT THERE IS A VASCULAR ELEMENT TO THE NERVE. NO PRE-OP COMPLAINTS OF LEG PAIN FROM THE PATIENT, ONLY BACK PAIN.

  Patient problems: Dyskinesia; Hyporesponsive to stimuli; Neuropathy; Peripheral Nervous Injury

  MAUDE report 13893723 ↗