ProDisc PDL-L-IP00SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034700014), received between Jun 12, 2018 and Jun 27, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON HAD A 2 LEVEL PRODISC-L AND WAS HAVING TROUBLE GETTING THE POLYETHYLENE INLAYS TO GO INTO THE IMPLANTED ENDPLATES DURING AN UNKNOWN PROCEDURE. THE SURGEON THOUGHT THE ANGLE OF THE ACCESS MIGHT BE PUTTING PRESSURE ON THE INSERTER CAUSING THE PROBLEMS. HOWEVER, THE SURGEON TRIED A COUPLE OF DIFFERENT POLY INLAYS AND CHANGED OUT THE ENDPLATES TRYING TO FIND A RESOLUTION. AFTER SEVERAL ATTEMPTS THE SURGEON PUT THE IMPLANTS TOGETHER ON THE BACK TABLE AND INSERTED IT AS ONE PIECE. AFTER THE CASE, SURGEON PLAYED WITH THE INSERTER AND A DEMO IMPLANT AND COULDN'T FIND ANYTHING APPARENTLY WRONG WITH THE INSTRUMENTATION. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. SURGICAL PROCEDURE OUTCOME AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INFERIOR END PLATE LARGE-STERILE. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740001 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON HAD A 2 LEVEL PRODISC-L AND WAS HAVING TROUBLE GETTING THE POLYETHYLENE INLAYS TO GO INTO THE IMPLANTED ENDPLATES DURING AN UNKNOWN PROCEDURE. THE SURGEON THOUGHT THE ANGLE OF THE ACCESS MIGHT BE PUTTING PRESSURE ON THE INSERTER CAUSING THE PROBLEMS. HOWEVER, THE SURGEON TRIED A COUPLE OF DIFFERENT POLY INLAYS AND CHANGED OUT THE ENDPLATES TRYING TO FIND A RESOLUTION. AFTER SEVERAL ATTEMPTS THE SURGEON PUT THE IMPLANTS TOGETHER ON THE BACK TABLE AND INSERTED IT AS ONE PIECE. AFTER THE CASE, SURGEON PLAYED WITH THE INSERTER AND A DEMO IMPLANT AND COULDN'T FIND ANYTHING APPARENTLY WRONG WITH THE INSTRUMENTATION. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. SURGICAL PROCEDURE OUTCOME AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INFERIOR END PLATE LARGE-STERILE . THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739982 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT WAS ORIGINALLY IMPLANTED SOMETIME IN 2013 WITH A PRODISC-L (PDL) TOTAL DISC REPLACEMENT AT SPINE DISC LEVELS L4-L5. PATIENT WAS IMPLANTED WITH ONE (1) PDL CONSTRUCT. THE CONSTRUCT INCLUDED A SUPERIOR END PLATE LARGE, POLYETHYLENE INLAY LARGE AND INFERIOR END PLATE LARGE. ON AN UNKNOWN DATE POST-OPERATIVE, THE PATIENT PRESENTED WITH A PARS FRACTURE WHICH CAUSED THE PATIENT CONSISTENT PAIN. THE PARS FRACTURE WAS LOCATED BEHIND THE PDL L4-L5 IMPLANT. IT IS UNKNOWN WHAT CAUSED THE PARS FRACTURE. ON (B)(6) 2018, THE SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A COMPETITOR¿S ANTERIOR FUSION WITH CAGE. INTER-OPERATIVE, DUE TO PATIENT'S SCAR TISSUE, THE PDL SUPERIOR END PLATE PROVED DIFFICULT TO REMOVE. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. THE PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR AN INFERIOR END PLATE LARGE-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 7593228 ↗