ShurFit Lumbar Interbody 72-IN-1001Recalls & reported problems
Precision Spine, Inc. · Curved Cage Implant Inserter · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019960403), received between Jan 13, 2025 and Jan 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
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.
MalfunctionJan 13, 2025Break; Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE SHURFIT 3D TITANIUM INTERBODY CAGE SYSTEM. THE SURGEON WAS USING A MALLET TO PLACE THE CAGE INTO THE PROPER POSITION WHEN THE TIP OF TWO DIFFERENT ASSEMBLY, INSERTER, POSTERIOR CURVED CAGE (72-IN-1001) BROKE. THE BROKEN PIECES WITH A PICKUP AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER SET THAT WAS READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. IT WAS NOTED THAT THE SURGEON INDICATED THE PATIENT HAD VERY HARD BONE AND DOES NOT ALLEGE THE DEVICE HAD ANYTIHNG TO DO WITH THE INSTRUMENT FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139086 ↗MalfunctionJan 13, 2025Break; Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE SHURFIT 3D TITANIUM INTERBODY CAGE SYSTEM. THE SURGEON WAS USING A MALLET TO PLACE THE CAGE INTO THE PROPER POSITION WHEN THE TIP OF TWO DIFFERENT ASSEMBLY, INSERTER, POSTERIOR CURVED CAGE (72-IN-1001) BROKE. THE BROKEN PIECES WITH A PICKUP AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER SET THAT WAS READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. IT WAS NOTED THAT THE SURGEON INDICATED THE PATIENT HAD VERY HARD BONE AND DOES NOT ALLEGE THE DEVICE HAD ANYTHING TO DO WITH THE INSTRUMENT FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139084 ↗
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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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