ALIF 03.808.104Recalls & reported problems
Synthes GmbH · ALIF TRIAL SPACER RASP-QUICK RELEASE 13MM HEIGHT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034724393), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2021, DURING A & P LUMBAR FUSION, WHILE PREPARING THE ENDPLATE FOR IMPLANT, ONE OF THE RASPS BROKE AT THE DISTAL END, ALLOWING THE HEAD TO FLOP FREELY AROUND. ANOTHER BACKUP SYNCAGE RASP TRAY, THAT WAS KEPT IN THE ROOM DURING ALIF PROCEDURES, WAS OPENED. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) ALIF TRIAL SPACER RASP-QUICK RELEASE 13MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11671019 ↗
Other RASP devices
- ATTUNE 2545-00-048Depuy (Ireland) · RASP22 reports
- P.F.C. 85-3927Depuy (Ireland) · RASP11 reports
- DePuy Sythes 10-306-000Symmetry Medical Inc. · Rasp11 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005613Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005610Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005614Zimmer, Inc. · Rasp3 reports
- ALIF 389.156Synthes GmbH · RASP3 reports
- ALIF 03.808.101Synthes GmbH · RASP2 reports
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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