ProLift L151-596Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00190837117610), received between Apr 22, 2021 and Jul 7, 2026 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Fracture

  IT WAS STATED THAT "TIP BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25734329 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS STATED "DISTAL TIP OF INSERTER BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742954 ↗
• MalfunctionJan 6, 2026Break

  IT WAS STATED THAT, "WHEN DISENGAGING FROM THE CAGE THE INSERTER BROKE." FOLLOW UP WITH COMPLAINANT RETURNED FOLLOWING RESPONSE: "THE INSERTER BROKE WHILE INSIDE THE PATIENT'S BODY. THE SURGEON AND TEAM PERFORMED MULTIPLE CHECKS WITH ADDITIONAL IMAGING AND DID NOT IDENTIFY THE BROKEN PIECE INTRAOPERATIVELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982569 ↗
• MalfunctionOct 21, 2025Fracture; Fracture

  IT WAS STATE THAT, "LONG PROLIFT INSERTER TIP FRACTURED AFTER ACGE WAS IMPLANTED AND SURGEON WAS ATTEMPTING TO DISENGAGE THE INSERTER. THE BROKEN PIECE OF THE TIP WAS SUCKED INTO THE NEPTUME AND CONFIRM TO BE THERE AND NOT IN THE PATIENT BY THE NURSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350411 ↗
• MalfunctionSep 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS STATED THAT, " TWO BROKEN PROLIFT EXPANDABLE INSTALLERS THAT BROKE... ONE BROKE DURING INSERTION AND THE OTHER CAME APART AFTERWARDS. NO HARM TO PATIENT OR DELAY OF CASE. NO COMPONENT LEFT IN PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962829 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS STATED THAT, "THE PROLIFT INSERTER INNER MECHANISM SNAPPED IN HALF. NO COMPONENT LEFT IN PATIENT. REPORTED DELAY: 3 MINS. THE SURGEON WAS MALLETING THE INTERBODY INTO THE DISC SPACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366690 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS STATED, "PROLIFT 10/12MM EXPANDABLE SPACER INSTALLER BROKE OFF DURING INTERBODY INSERTION. NO COMPONENT LEFT IN PATIENT. THE FRACTURED COMPONENT FELL INTO THE PATIENT'S BODY AND WAS SUCCESSFULLY RETRIEVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179568 ↗
• InjuryJun 10, 2025Fracture; Fracture

  IT WAS STATED, "PROLIFT EXPANDABLE INSERTER BROKEN TONGS AT DISTAL TIP. INTERBODY LOOKED CROOKED UNDER X-RAY IMAGING. PROLIFT EXPANDABLE CAGE STILL PERFORMED AS INTENDED. UNKNOWN WHEN TONGS OF INSERTER WERE BROKEN. BOTTOM OF INSERTER TONGS STILL REMAINED ATTACHED TO INSERTER; COMPONENT LEFT IN PATIENT: UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED. CAGE WAS STILL ABLE TO BE INSERTED AND EXPANDED TO STANDARDS. THE COMPONENT THAT WAS LEFT POTENTIALLY IN PATIENT WAS A PIECE OF THE INSERTER PRONG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177082 ↗
• InjuryNov 22, 2024Fracture; Fracture

  2 PROLIFT INSERTERS BROKE WHILE TRYING TO REMOVE CAGE THAT WAS TOO ANTERIOR WITH SLAP HAMMER, NO COMPONENT LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761342 ↗
• InjuryMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHEN REMOVING THE PROLIFT 10MM INSERTER, THE DURAL WAS TORN CAUSING A DURAL TEAR.

  Patient problems: Laceration(s)

  MAUDE report 16986242 ↗
• InjuryMay 12, 2023Fracture; Fracture

  TIP OF PROLIFT INSTALLER BROKE OFF AND WAS LODGED IN THE DISC SPACE. THE PIECE OF THE BROKEN INSTALLER WAS RETRIEVED BUT IT TOOK ADDITIONAL DECOMPRESSION AND A DELAY OF 40 MINS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16924564 ↗
• MalfunctionJan 16, 2023Fracture; Fracture

  THE PROLIFT INSERTER PRONG BROKE INSITU. THE PIECE WAS RETRIEVED, BUT CAUSED A DELAY OF 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16175366 ↗
• InjuryDec 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DISTAL TIP OF PROLIFT JAWS SHEERED OFF DURING INSERTION. THERE WAS A DURAL TEAR INJURY.

  Patient problems: Laceration(s)

  MAUDE report 16068482 ↗
• MalfunctionAug 19, 2022Material Fragmentation; Material Fragmentation

  INSTALLER BROKE OFF DURING SURGERY, A PIECE WAS LEFT IN THE PATIENT BUT SURGEON WAS ABLE TO RETRIEVE THE BROKEN PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262619 ↗
• MalfunctionFeb 16, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PROLIFT INSERTER TIPS BROKE WHILE ATTACHED TO THE CAGE IN THE DISC SPACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13541990 ↗
• InjuryJan 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE PROLIFT INSERTER FRACTURED WHILE DISENGAGING FROM A CAGE INTRA-OPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 13309641 ↗
• MalfunctionApr 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE INSTALLER BROKE OFF WHILE TRYING TO MANIPULATE TGE CAGE AND FELL OFF INTO THE PATIENT, TIP RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11709729 ↗