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VERTE-STACK® Spinal System 6278244Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 6278244 CRNS PSR 12 X 14 X 14MM · 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 00721902807527), received between Dec 28, 2016 and Dec 28, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1

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.

  • MalfunctionDec 28, 2016Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: CERVICAL STENOSIS. FOR WHICH PATIENT UNDERWENT A CERVICAL CORPECTOMY AT LEVELS C4-C7. INTRA-OP, THE 3 PIECES WERE SNAPPED TOGETHER AND THEN PACKED WELL WITH BONE. IMPLANT WAS IMPLANTED AND X-RAY WAS TAKEN WHICH REVEALED THAT END CAP HAD SEPARATED SLIGHTLY FROM THE STRUT, IT WAS REMOVED AND EXAMINED. IT WAS CLEANED OFF AND RE ATTACHED TOGETHER BUT ONCE IN PATIENT, THE END CAP WAS LOOSE. THEREFORE IT WAS DECIDED TO OPEN UP A NEW MIDDLE STRUT AND 2 NEW ENDCAPS WHICH WORKED VERY WELL. PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6208060 ↗

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