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WAVE D SPINAL SYSTEM 2661224Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 2661224 WAVE D 12MM X 24MM 6DEG · Class 2 · Implant

Data updated Oct 16, 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 00643169245235), received between Nov 10, 2021 and Nov 10, 2021 — 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

Device problems

  • Break1

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.

  • MalfunctionNov 10, 2021Break; Break

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR L4-5 STENOSIS. PROCEDURE OR TECHNIQUE USED WAS MIS TLIF. IT WAS REPORTED THAT THE EXPANSION PLUG CRACKED IN HALF. IT WAS EXPLANTED AND A NEW IMPLANT WAS OPENED AND IMPLANTED WITHOUT EVENT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12791885 ↗

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Sources and updates

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