Skip to content

VERTE-STACK® Spinal System 6241041Recalls & reported problems

Medtronic Sofamor Danek, Inc. · STRUT 6241041 ANATOMIC 14X11X5MM · 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 00613994305244), received between May 5, 2020 and May 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Patient-Device Incompatibility1

Patient problems

  • Cancer1
  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 5, 2020Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

    PATIENT IMPLANTED WITH BIOLOGIC INFUSE RHBMP-2 USED IN COMBINATION WITH MODULAR VERTE-STACK ANATOMIC PEEK COMPONENTS FOR C5 SINGLE-LEVEL CERVICAL VERTEBRAL BODY REPLACEMENT (CORPECTOMY) AND C4-5/C5-6 ANTERIOR CERVICAL DISCECTOMY AND FUSION. PATIENT WAS NOT INFORMED OF 2008 FDA PUBLIC NOTICE WARNING OF LIFE-THREATENING COMPLICATIONS REFERENCING USE OF RHBMP-2 IN THE CERVICAL SPINE, NOR WAS PATIENT INFORMED THAT USE OF THE VERTE-STACK COMPONENTS IN THE CERVICAL SPINE IS CONTRAINDICATED ON THE DEVICE LABELING CLEARED BY THE FDA [K070173]. HTTPS://WEB.ARCHIVE.ORG/WEB/20160801140944/HTTPS://WWW.FDA.GOV/CDRH/510K/K070173.PDF. STUDIES SHOW RHBMP-2 EXPRESSION ASSOCIATED WITH METASTATIC PROSTATE CANCER PATIENTS [HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/2130271]. IN (B)(6) 2020, PATIENT WAS DIAGNOSED WITH METASTATIC PROSTATIC CANCER EXTRACAPSULAR INVOLVEMENT THROUGH PSA VELOCITY, MRI, FUSION BIOPSY AND HISTOLOGY. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: Cancer; Failure of Implant

    MAUDE report 10028419 ↗

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.