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VERTE-STACK® Spinal System 9192507Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 9192507 CRESCENT PEEK 25X7 · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074520544), received between Sep 5, 2017 and Sep 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 5, 2017Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS LUMBAR DEGENERATION. FOR WHICH, PATIENT UNDERWENT POSTERIOR LUMBER INTERBODY FUSION (PLIF) AT LEVELS L2-5. INTRA-OP, DURING THE IMPLANTATION OF CAGE, THE SURGEON HAD TO IMPACT THE CAGE TO GET IT INTO THE DISC SPACE, DURING WHICH THE CAGE BROKE. ANOTHER CAGE WAS USED FOR INSERTION WHICH TOO BROKE DURING IMPACTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6841133 ↗
  • MalfunctionSep 5, 2017Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS LUMBAR DEGENERATION. FOR WHICH, PATIENT UNDERWENT POSTERIOR LUMBER INTERBODY FUSION (PLIF) AT LEVELS L2-5. INTRA-OP, DURING THE IMPLANTATION OF CAGE, THE SURGEON HAD TO IMPACT THE CAGE TO GET IT INTO THE DISC SPACE, DURING WHICH THE CAGE BROKE. ANOTHER CAGE WAS USED FOR INSERTION WHICH TOO BROKE DURING IMPACTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6841129 ↗

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