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A-CIFT® SoloFuse® 01-32017-06Recalls & reported problems

Spinefrontier, Inc. · A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 6mm · Class 2 · Implant

Data updated Oct 13, 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 00190361021575), received between May 17, 2019 and May 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 17, 2019Fracture; Fracture

    SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE 6MM A-CIFT SOLOFUSE INTERBODY WAS OBSERVED TO BE CRACKED WHEN ATTEMPTING TO PLACE THE SCREWS, A MALLET WAS USED TO POSITION THE IMPLANT. THERE WAS NO IMPACT TO PATIENT AS A RESULT OF THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8621996 ↗

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Sources and updates

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