ALIF 03.808.101Recalls & reported problems
Synthes GmbH · ALIF TRIAL SPACER RASP WITH HANDLE-7MM HEIGHT · Class 1
Data updated Oct 16, 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 10705034724362), received between Jan 6, 2023 and Oct 31, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
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.
MalfunctionOct 31, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A INSTRUMENT BROKE DURING USE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20581295 ↗MalfunctionJan 6, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ALIF RASP BROKE OFF DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FRAGMENTS WERE GENERATED, AND THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ALIF TRIAL SPACER RASP WITH HANDLE-7MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16112586 ↗
Other RASP devices
- ATTUNE 2545-00-048Depuy (Ireland) · RASP22 reports
- DePuy Sythes 10-306-000Symmetry Medical Inc. · Rasp11 reports
- P.F.C. 85-3927Depuy (Ireland) · RASP11 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005613Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005614Zimmer, Inc. · Rasp3 reports
- ALIF 389.156Synthes GmbH · RASP3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005610Zimmer, Inc. · Rasp3 reports
- LIBERATOR 25.50016Conmed Corporation · RASP1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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