VERTE-STACK® Spinal System 9193014Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 9193014 CRESCENT PEEK 30X14 · Class 2 · Implant
- 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 00885074520742), received between Nov 18, 2025 and Nov 18, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
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 18, 2025Break; Crack; Break; Crack
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF-TRANSFORAM INAL LUMBAR INTERBODY FUSION SPINAL THERAPY FOR LUMBAR DEGENERATION REQUIRING 2 LEVEL TLIF PROCEDURE. LEVELS IMPLANTED AT L4/5 AND L5/S1. IT WAS REPORTED THAT AS THE SURGEON WAS STARTING TO PLACE THE CAGE INSITU IN THE DISC SPACE HE STARTED TO IMPACT THE INSERTER AND SUDDENLY THE CAGE CRACKED/BREAKAGE. THE CAGE LOOKED TO HAVE BEEN ATTACHED PROPERLY TO THE INSERTER BY THE SCRUB NURSE AND ALSO WASN¿T BEING FORCED INTO THE DISC SPACE WITH UNDUE FORCE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23581103 ↗
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- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.