Prodisc L PDL-M-SP03SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00843193114983), received between Mar 24, 2022 and Mar 25, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 20 most recent of 20 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 24690311 ↗
• 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 24035789 ↗
• 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 23837913 ↗
• 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 23436085 ↗
• 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. 1) THERE IS NO CONCERN WITH THE IMPLANT OR THE IMPLANT PLACEMENT, 2) THIS IS AN UNCOMMON BUT POTENTIAL COMPLICATION FOR WHICH THERE ARE NO RELIABLE PRE-OPERATIVE TESTS OR INDICATORS, 3) PATIENT WILL HAVE A CT MYELOGRAM DONE TO RULE OUT ANY COMPRESSION UNABLE TO BE IDENTIFIED WITH THE EXISTING POST OP MRI, AND 4) PATIENT WILL CONTINUE MEDICATION AND THERAPY IN HOPES OF REGAINING FUNCTION IN THE FOOT.

  Patient problems: Movement Disorder

  MAUDE report 23008512 ↗
• 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. 1) THERE IS NO CONCERN WITH THE IMPLANT OR THE IMPLANT PLACEMENT, 2) THIS IS AN UNCOMMON BUT POTENTIAL COMPLICATION FOR WHICH THERE ARE NO RELIABLE PRE-OPERATIVE TESTS OR INDICATORS, 3) PATIENT WILL HAVE A CT MYELOGRAM DONE TO RULE OUT ANY COMPRESSION UNABLE TO BE IDENTIFIED WITH THE EXISTING POST OP MRI, AND 4) PATIENT WILL CONTINUE MEDICATION AND THERAPY IN HOPES OF REGAINING FUNCTION IN THE FOOT.

  Patient problems: Movement Disorder

  MAUDE report 23008495 ↗
• 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 22193243 ↗
• 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 21510205 ↗
• 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 21230137 ↗
• 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 21230104 ↗
• 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 20893945 ↗
• 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 20350779 ↗
• 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 19404453 ↗
• 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 18950122 ↗
• 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 17376051 ↗
• InjuryMay 24, 2023Expulsion; Expulsion

  THE PATIENT WAS IMPLANTED WITH A PRODISC L IMPLANT ON (B)(6) 2023 AT L5-S1 LEVEL. APPROXIMATELY TWO WEEKS AFTER THE IMPLANTATION SURGERY THE PATIENT REPORTED HEARING AND FEELING A POPPING NOISE IN HER LUMBAR SPINE. X-RAY IMAGES SHOWED THAT THE SUPERIOR END PLATE APPEARS TO HAVE DISLODGED ANTERIORLY. THE IMPLANT WAS REMOVED ON (B)(6) 2023. THE PDL DEVICE WAS REPLACED WITH A BONE ALIF WITH SCREWS AND WASHERS AND SUBSEQUENT FIXATION WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 16991529 ↗
• 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 16855436 ↗
• InjuryApr 6, 2023Expulsion; Expulsion

  A PATIENT WAS IMPLANTED WITH TWO PRODISC L DEVICES AT L4/L5 AND L5/S1 ON (B)(6) 2021. IT WAS FOUND THAT THE POLY INLAY HAD EXPULSED ANTERIORLY FROM THE ENDPLATES AT THE L5/S1 LEVEL. THE SURGEON PERFORMED A PDL REMOVAL OF THAT LEVEL ON (B)(6) 2023. PATIENT WAS THEN FUSED USING A CAGE AND POSTERIOR PEDICLE SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 16690106 ↗
• 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. 10MIN 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 13893871 ↗
• 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. 10MIN 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 13893684 ↗