Matrixx System 54M-30-12-SPRecalls & reported problems
Nexxt Spine, LLC · TLIF Oblique 30D x 10W x 12H · Class 2 · Implant
Data updated Oct 18, 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 00889929026229), received between Mar 18, 2019 and Mar 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2019Fracture; Fracture
IT WAS REPORTED ON (B)(6) 2019 THAT A TLIF OBLIQUE IMPLANT FRACTURED DURING THE INSERT AND ROTATE TECHNIQUE. THE PROCEDURE INVOLVED THE IMPLANTATION OF TWO TLIF OBLIQUE CAGES. ONE WAS SUCCESSFUL. THE SURGEON POUNDED A SECOND 30DX10WX12H TLIF OBLIQUE IMPLANT INTO A 4MM DISC SPACE, INCREASING THE DISC SPACE TO 10MM TO ACCOMMODATE THE INTERBODY. WHEN ROTATING FROM 10MM TO 12MM ORIENTATION, THE INTERBODY BROKE. THE SURGEON USED EXCESSIVE FORCE TO ROTATE THE INTERBODY WHICH EXCEEDED THE DESIGN LIMITS FOR ROTATION. THE IMPLANT WAS INVESTIGATED TO BE SECURE, AND NO PIECES BROKE OFF OR FELL INTO THE WOUND, SO IT WAS LEFT IN PLACE TO PERFORM ITS INTENDED FUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8430343 ↗
Other Spinal Vertebral Body Replacement Device devices
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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