Prodisc L PDL-M-SP11SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843193111807), received between Mar 12, 2021 and Mar 17, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Expulsion; Expulsion

  A PATIENT RECEIVED A 2-LEVEL PRODISC L CONSTRUCT AT L4/5 AND L5/S1 ON (B)(6) 2020. THE PATIENT HAD A LIFTING EPISODE AT THE ONSET OF SYMPTOMS APPROXIMATELY 1 YEAR POST-OP. THE PATIENT X-RAY IMAGING SHOWED BILATERAL PEDICLE FRACTURES OF L4 AND L5 AS WELL AS INLAY EXPULSION OF THE L5/S1 PRODISC L IMPLANT. PEER TO PEER REVIEW OF THE PATIENT SUGGESTED THERE WAS NO SPACE BETWEEN THE FACETS OF THE INVOLVED VERTEBRAE WHICH PLACED STRESS ALONG THE PEDICLES. A HEAVY LIFTING ACTIVITY COULD HAVE CREATED THE FORCE TO CAUSE THE BILATERAL FRACTURES. IN (B)(6) 2022 THE PATIENT UNDERWENT REVISION BY A DIFFERENT UNKNOWN SURGEON TO REMOVE THE PRODISC L IMPLANT FROM L5/S1 AND REPLACE IT WITH AN UNKNOWN FUSION CAGE WITH INTEGRATED FIXATION. THE PATIENT ALSO RECEIVED POSTERIOR FIXATION FROM L4 TO S2.

  Patient problems: Vertebral Fracture

  MAUDE report 13792280 ↗
• InjuryFeb 4, 2022Biocompatibility; Biocompatibility

  PATIENT CONTACTED CENTINEL SPINE REGARDING THE MATERIAL COMPOSITION OF PRODISC L US. THE PATIENT RECEIVED A PRODISC L AT L5/S1 ON (B)(6) 2020. THE PATIENT RECENTLY LEARNED THEY HAVE SOME STRONG METAL ALLERGIES. THE PATIENT REQUESTED INFORMATION ON THE METAL ALLOYS AND PERCENTAGE USED IN PRODISC L. THE PATIENT ALSO HAD CERVICAL SPINE SURGERY IN 2019 AND TOTAL SHOULDER REPLACEMENT IN 2021. LOT NUMBERS OF THE PRODISC L DEVICES WERE PROVIDED. FURTHER COMMUNICATIONS INDICATE THE PATIENT IS ALLERGIC TO MOLYBDENUM, NICKEL, ALUMINUM, TANTALUM, TIN, PLATINUM, CADMIUM, GALLIUM. THE PATIENT IS NOT HAVING COMPLICATIONS WITH THE PRODISC L DEVICE BEYOND AN ALLERGY TO SOME OF THE MATERIALS. THE PATIENT REPORTED HAVING A HIGH CONCENTRATION OF MOLYBDENUM IN AN UNRELATED TOTAL SHOULDER IMPLANT. THE SHOULDER IMPLANT HAS SWELLING, PAIN, WEAKNESS, DECREASED ROM, NUMBNESS IN THE SKIN, AND DELAYED HEALING. THE INFLAMMATION HAS SPREAD AND IS IMPACTING THE REST OF THE PATIENT'S BODY (SYSTEMIC). PATIENT REPORTS ENTIRE BODY IS PAINFUL AND TIRES (EXHAUSTED) EASILY. THE OTHER IMPLANTS IN THE CERVICAL (UNKNOWN MFG DEVICE) AND LUMBER SPINE (PRODISC L) HAVE BECOME MORE PAINFUL AND THE PATIENT BELIEVES THIS IS DUE

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 13457686 ↗
• MalfunctionAug 18, 2021Mechanical Problem; Off-Label Use; Use of Device Problem; Mechanical Problem; Off-Label Use; Use of Device Problem

  A PATIENT WAS SCHEDULED AND DIAGNOSED FOR PRODISC L IMPLANTATION AT L5-S1. THE PATIENT UNDERWENT IMPLANTATION SURGERY ON (B)(6) 2021. DURING THE PROCEDURE, THE ACCESS SURGEON PROVIDED A LIMITED WINDOW TO THE VERTEBRAL LEVEL. THE SPINE SURGEON PREPARED THE DISC SPACE AND INSERTED THE PRODISC L ENDPLATES INTO THE DISC SPACE. THE SURGEON THEN PROCEEDED TO PLACE THE PE INLAY INTO THE ENDPLATES WITHOUT FOLLOWING THE INDICATED SURGICAL TECHNIQUE FORM PRODISC L. THE DISTRACTOR WAS NOT USED TO PROGRESS THE INLAY INTO PLACE AND OPEN THE DISC SPACE. THE INLAY WAS PUSHED AND MALLET INTO PLACE USING ONLY THE INLAY PUSHER. THE SURGEON THOUGHT THE INLAY WAS SEATED, BUT ONCE THE INSERTER WAS REMOVED HE REALIZED THE INLAY WAS NOT PROPERLY SEATED. THE SURGEON COULD NOT RE-ATTACH THE INSERTER TO FULLY SEAT THE INLAY. IT WAS AT THIS POINT THE SURGEON DECIDED THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE PE INLAY AND CLOSE THE PATIENT WITH THE ENDPLATE INTACT. THE PATIENT APPEARED TO HAVE RESTORED DISC HEIGHT AND THE ENDPLATES WERE POSITIONED WELL ENOUGH FOR THE SURGEON TO FEEL CONFIDENT THE SURGERY WAS A SUCCESS FROM A NEUROLOGICAL STANDPOINT. THE SURGEON INDICATED DIRECTLY THAT THERE WAS NO PROBL

  Patient problems: Loss of Range of Motion

  MAUDE report 12337979 ↗
• MalfunctionJun 4, 2021Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  A PRODISC L REMOVAL PROCEDURE HAS BEEN PERFORMED ON MONDAY (B)(6) 2021. THE PDL IMPLANT IS BEING REMOVED DUE TO PE INLAY MIGRATION AND SUPERIOR ENDPLATE MIGRATION. A LATERAL X-RAY IMAGE WAS PROVIDED SHOWING THE MALFUNCTION. DATE OF EVENT/DIAGNOSIS WAS (B)(6) 2021. THE PATIENT HAS PAIN WHICH STARTED ABOUT 3 WEEKS AGO AFTER HAVING SPINAL TRACTION DONE AT HER CHIROPRACTOR. THE PATIENT DID NOT HAVE ANY COMORBIDITIES. THE SURGEON BELIEVES THAT AN UNKNOWN TRAUMATIC INJURY WAS THE CAUSE OF THE PDL INLAY MIGRATION. MRI REVEALED BILATERAL FRACTURES OF THE L5 PEDICLES. THE SURGEON DOES NOT BELIEVE THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION OR SYMPTOMS. THE SURGEON REPLACED THE PDL WITH A BONE ALIF AND POSTERIOR FIXATION. THE CASE WAS COMPLETED WITHOUT ANY INCIDENT OR DIFFICULTY.

  Patient problems: Pain; Vertebral Fracture

  MAUDE report 11938264 ↗
• MalfunctionMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PATIENT RECEIVED A PRODISC L CONSTRUCT ON (B)(6) 2018. DURING A PATIENT FOLLOW UP APPOINTMENT ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF PAIN. IMAGING WAS TAKEN ON AN UNKNOWN DATE AT OR AFTER THE FOLLOW UP EXAM. THE IMAGING REVEALED THE PRODISC L PE INLAY HAD DISLODGED FROM THE INFERIOR ENDPLATE. THE PE INLAY EXPULSION IS LIKELY TO LEAD TO SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY.

  Patient problems: Pain

  MAUDE report 11585655 ↗
• InjuryMar 12, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  PATIENT RECEIVED A PRODISC L MEDIUM 10MM IMPLANT AT L5-S1 ON (B)(6) 2020. THE PATIENT CAME FOR THE FIRST TIME TO FOLLOW UP WITH THE SURGEON. THE PATIENT HAD BACK PAIN STARTING 1 WEEK PRIOR TO THE FOLLOW UP EXAM WITH THE SURGEON. THE PATIENT INDICATED NOTHING HAPPENED WHEN THE PAIN STARTED. THE SURGEON HAS NOT PROVIDED A POSSIBLE REASON FOR THE MIGRATION OR INLAY EXPULSION. THERE HAS BEEN NO INDICATION THE PATIENT HAS ANY CONTRIBUTING COMORBIDITIES. A REMOVAL PROCEDURE WAS SCHEDULED FOR (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11474566 ↗