ProDiscRecalls & reported problems across all models

We found 9 models of ProDisc by Synthes (U.S.A.) LP in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2013 and May 14, 2026 — classified as 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ProDisc problems

ProDisc models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ProDisc PDL-M-SP11S

  PROSTHESIS, INTERVERTEBRAL DISC
  5 reports
• ProDisc PDL-M-IP00S

  PROSTHESIS, INTERVERTEBRAL DISC
  4 reports
• ProDisc PDL-L-IP00S

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• ProDisc PDL-L-PT10S

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• ProDisc PDL-M-PT10S

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• ProDisc PDL-L-SP11S

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• ProDisc PDL-M-SP06S

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• ProDisc PDL-L-PT14S

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• ProDisc PDL-L-SP06S

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report

Recent ProDisc adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171582 ↗
• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171495 ↗
• MalfunctionMay 14, 2026Expulsion

  A PATIENT WAS IMPLANTED WITH A PRODISC L DEVICE APPROXIMATELY 15 YEARS AGO. THE PATIENT FOLLOWED UP WITH THE IMPLANTATION SURGEON AFTER EXPERIENCING INCREASED LOWER BACK PAIN WHILE SQUATTING. IMAGING WAS REVIEWED ON A PEER-TO-PEER DISCUSSION IT WAS DETERMINED THAT THE POLY INLAY WAS EXPULSED OR EXPULSING. THE PATIENT IS ASYMPTOMATIC AND THIS WAS CONSIDERED AN ANCILLARY RADIOGRAPHIC FINDING. SURGEON WAS GOING TO DISCUSS POSSIBLE MEDICAL OR SURGICAL INTERVENTIONS WITH THE PATIENT. AT THIS TIME NO INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171494 ↗
• InjuryJan 30, 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) 2019. PATIENT EXPERIENCED INSTABILITY AT THE LEVEL DUE TO A BILATERAL PARS FRACTURE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED ON (B)(6) 2025.

  Patient problems: Bone Fracture(s)

  MAUDE report 21273796 ↗
• InjuryJan 30, 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) 2019. PATIENT EXPERIENCED INSTABILITY AT THE LEVEL DUE TO A BILATERAL PARS FRACTURE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED ON (B)(6) 2025.

  Patient problems: Bone Fracture(s)

  MAUDE report 21273785 ↗
• InjuryJan 30, 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) 2019. PATIENT EXPERIENCED INSTABILITY AT THE LEVEL DUE TO A BILATERAL PARS FRACTURE. THE PDL IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED ON (B)(6) 2025.

  Patient problems: Bone Fracture(s)

  MAUDE report 21273771 ↗
• InjuryOct 3, 2023Expulsion; Expulsion

  PATIENT RECEIVED A PRODISC L DEVICE ON (B)(6) 2009 DUE TO DEGENERATIVE DISC DISEASE AT L4-5. IT WAS FOUND THAT THE POLY HAD DISPLACED ANTERIORLY. THE PDL WAS REMOVED ON (B)(6) 2023 AND THE PATIENT CONVERTED TO AN ALIF. PRE-REMOVAL IMAGING WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17865593 ↗
• InjuryOct 3, 2023Expulsion; Expulsion

  PATIENT RECEIVED A PRODISC L DEVICE ON (B)(6) 2009 DUE TO DEGENERATIVE DISC DISEASE AT L4-5. IT WAS FOUND THAT THE POLY HAD DISPLACED ANTERIORLY. THE PDL WAS REMOVED ON (B)(6) 2023 AND THE PATIENT CONVERTED TO AN ALIF. PRE-REMOVAL IMAGING WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17865588 ↗
• 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) POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10 MM-STERILE. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740066 ↗
• 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) POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740047 ↗
• 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) POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740034 ↗
• 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 ↗
• 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) SUPERIOR END PLATE LARGE 11°-STERILE. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739949 ↗
• 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) SUPERIOR END PLATE LARGE 11°-STERILE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739925 ↗

Other Synthes (U.S.A.) LP products

• MAXFRAME4 models · 30 reports
• ProDisc-C11 models · 24 reports