SABER LUMBAR I/F CAGE 287001008Recalls & reported problems
Depuy Spine, LLC · SABER LUMBAR I/F CAGE SYSTEM DISC SHAVER 8mm · 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 10705034215617), received between Jan 18, 2022 and Aug 6, 2024 — 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
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED INTRAOPERATIVELY, AN ANATOMIC SHAVER BROKE IN THE PATIENT¿S DISC SPACE WHILE IN USE. ANOTHER SET WAS CALLED AND OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE TO TEN (5-10) MINUTE SURGICAL DELAY. THIS REPORT IS FOR A DISC SHAVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19917194 ↗MalfunctionJan 18, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENT BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SABER LUMBAR I/F CAGE SYSTEM DISC SHAVER 8MM. THIS IS REPORT 9 OF 14 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13280507 ↗
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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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