VERTE-STACK® Spinal System 9192510Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 9192510 CRESCENT PEEK 25X10 · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074520582), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
InjuryJan 5, 2021Migration; Migration
INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OP DIAGNOSIS OF L4-5 TLIF. IT WAS REPORTED THAT DURING TLIF PROCEDURE THROUGH QUANDRANT RETRACTORS THE CAGE FLIPPED BEHIND THE SPINAL CORD WHEN TRYING TO INSERT IT INTO THE DISC SPACE DUE TO THE INSERTER GETTING LOOSE. THERE WAS 2 HOURS SURGICAL DELAY DUE TO REPORTED PRODUCT MALFUNCTION. CAGE HAD TO BE RETRIEVED THROUGH MIDLINE APPROACH. LAMINECTOMY HAD TO BE PERFORMED IN ADDITION TO REACH THE CAGE. THERE WAS NO INSTRUMENT OR IMPLANT BREAK. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11116778 ↗
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- 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.