ShurFit Interbody Device ALIF0832-11PRecalls & reported problems
Precision Spine, Inc. · ALIF Cage Peek 8 degree 11mm x 32mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019912075), received between Dec 30, 2025 and Dec 30, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT A 5 LEVEL PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE SHURFIT ALIF INTERBODY CAGE SYSTEM. FOLLOWING INSERTION OF SIZE 11 TRIAL, WHILE ATTEMPTING TO INSERT AN ALIF CAGE PEEK 8 DEGREE 11MM X 32MM (ALIF0832-11P) IN L2, THE CAGE CRACKED ACROSS THE CAGE ALONGSIDE THE THREADED INSERTER ASSEMBLY HOLE. THE BROKEN CAGE WAS REMOVED AND WHILE A SECOND CAGE OF THE SAME SIZE WAS BEING INSERTED, IT ALSO CRACKED IN THE SAME WAY. THIS CAGE WAS REMOVED AND A THIRD CAGE OF THE SAME SIZE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY, BUT A DELAY TO THE PROCEDURE OF TWENTY-FOUR MINUTES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927947 ↗InjuryDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT A 5 LEVEL PROCEDURE WAS PERFORMED ON DECEMBER 2, 2025, UTILIZING THE SHURFIT ALIF INTERBODY CAGE SYSTEM. FOLLOWING INSERTION OF SIZE 11 TRIAL, WHILE ATTEMPTING TO INSERT AN ALIF CAGE PEEK 8 DEGREE 11MM X 32MM (ALIF0832-11P) IN L2, THE CAGE CRACKED ACROSS THE CAGE ALONGSIDE THE THREADED INSERTER ASSEMBLY HOLE. THE BROKEN CAGE WAS REMOVED AND WHILE A SECOND CAGE OF THE SAME SIZE WAS BEING INSERTED, IT ALSO CRACKED IN THE SAME WAY. THIS CAGE WAS REMOVED AND A THIRD CAGE OF THE SAME SIZE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY, BUT A DELAY TO THE PROCEDURE OF TWENTY-FOUR MINUTES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927946 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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