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VERTEX® Reconstruction System 6955506Recalls & reported problems

Medtronic Sofamor Danek, Inc. · BONE SCREW 6955506 4.5 X 6MM CORTICAL · 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 00885074239248), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

  • Device Slipped1
  • Failure to Align1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 17, 2018Device Slipped; Failure to Align; Failure to Align

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION DUE TO CERVICAL SPONDYLOSIS. INTRA-OP, BONE SCREW WAS FOUND SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7693332 ↗

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.