ProDisc PDL-L-SP11SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034700090), received between Jun 27, 2019 and Jun 27, 2019 — classified as 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 2 most recent of 2 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) 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 ↗