WAVE D SPINAL SYSTEM 2660924Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 2660924 WAVE D 9MM X 24MM 6DEG · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169245174), received between Jun 22, 2020 and Jul 2, 2020 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
- Spinal Cord Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2020Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE THAT DURING THE SPINAL FUSION PROCEDURE ON A PATIENT DIAGNOSED WITH STENOSIS, THE SUPERIOR AND INFERIOR PORTIONS BROKE OFF OF THE POSTERIOR PORTION OF THE CAGE, RESULTING IN 4 PIECES INCLUDING THE CENTER PIECE FOR EXPANSION. THE BREAKAGE CAUSED A SMALL DURAL TEAR WHICH WAS REPAIRED. ALL PIECES OF THE CAGE WERE EXPLANTED. THE DAMAGED PRODUCT IS AVAILABLE FOR RETURN AND WAS REPLACED WITH A MEDTRONIC PRODUCT. NO ADDITIONAL SURGERY/TREATMENT WAS PERFORMED ON THE PATIENT.
Patient problems: Spinal Cord Injury
MAUDE report 10222512 ↗MalfunctionJun 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-S1. INTRA-OP, THE TREATED LEVEL WAS EXTREMELY COLLAPSED AND THE MARKERS ON THE DEVICE INDICATED THAT THE DISTRACTION PLUG OF THE DEVICE WAS PUSHED OUT OF THE INTERBODY DEVICE MEDIALLY RATHER THAN LOCKING INTO ITS PLACE ANTERIORLY. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL TREATMENT WAS PERFORMED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10178781 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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