WAVE D SPINAL SYSTEM 2621224Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169245242), received between May 7, 2017 and May 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 7, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 LEVEL DUE TO L5-S1 SPINAL STENOSIS AND DEGENERATIVE DISC DISORDER. INTRA-OP, CAGE WAS INSERTED INTO THE DISC SPACE, HOWEVER DEVICE FAILED TO EXPAND CORRECTLY. THE INNER SPACER CRACKED UNDER THE STRESS AND TENSION HALFWAY THROUGH EXPANSION. AN AUDIBLE SNAP WAS HEARD. A LATERAL X-RAY SHOWED THE CAGE WAS BROKEN IN THE MIDDLE. THE DEVICE WAS COLLAPSED AND COMPLETELY REMOVED FROM DISK SPACE WHILE STILL ATTACHED TO THE INSERTER. THE SLAP HAMMER WAS USED. UPON IMMEDIATE REVIEW IT WAS OBVIOUS THAT THE CAGE FAILED UNDER TENSION. A SIMILAR CAGE WAS SELECTED AND INSERTED SUCCESSFULLY INTO THE DISK SPACE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6550859 ↗