FUSE ™ SPINAL SYSTEM 2881124Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 2881124 FUSE 11MM X 24MM 8DEG · 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 00643169245525), received between May 15, 2017 and Jul 3, 2017 — 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Injury1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH MEDWATCH THAT POST-OP, THE PATIENT SUFFERED FROM UNKNOWN SERIOUS INJURY AND REQUIRED INTERVENTION. THE PATIENT UNDERWENT L3-L5 DECOMPRESSION WITH DECOMPRESSIVE LAMINECTOMIES AND FACETECTOMIES, POSTEROLATERAL STABILIZATION WITH PEDICLE SCREWS AND RODS FROM L3 THROUGH L5 RIGHT SIDED TRANSFORAMINAL LUMBAR INTERBODY FUSION.
Patient problems: Injury; No Code Available
MAUDE report 6683791 ↗MalfunctionMay 15, 2017Break; Break
IT WAS REPORTED THAT PATIENT WITH CENTRAL STENOSIS AND GRADE I SPONDYLOLISTHESIS UNDERWENT TRANSFORAMINAL INTERBODY FUSION AT LEVELS L4-L5. INTRA -OP, CAGE BROKE OFF AT 1/3 POINT WHERE GRAFT CONTAINMENT CHAMBER BEGINS. THIS OCCURRED DURING ROTATION OF IMPLANT. AFTER PLACEMENT THE SURGEON WENT TO ROTATE THE IMPLANT AND THE IMPLANT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY IS PERFORMED YET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6566161 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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 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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