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VERTEX® Reconstruction System 6958924Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 6958924 4.5 X 24MM MAS · 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 00613994354518), received between Nov 21, 2017 and Nov 21, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • 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.

  • InjuryNov 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED VIA A PATIENT CALL THAT THE PATIENT UNDERWENT SPINAL (CERVICAL/ THORACIC) FUSION SURGERY. POST-OP, SCREWS LOOSENING WERE REPORTED. THE PATIENT HAD 3 ADDITIONAL SURGERIES AND HAD PSEUDOARTHROSIS DOCUMENTED WHEN THE DEVICES WERE REMOVED.

    Patient problems: Failure of Implant

    MAUDE report 7047839 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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