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VERTEX® Reconstruction System 6958716Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 6958716 3.5 X 16MM MAS · Class 2 · Implant

All models of VERTEX Reconstruction System (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00613994355034), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionDec 4, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL SURGERY DUE TO CERVICAL VERTEBRA DEGENERATION. INTRA-OP, THE SCREW WAS DISASSEMBLED INTO 3 PARTS, NAIL, NUT, AND RING. NO FRAGMENTS WERE REMAINED IN THE PATIENT BODY. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE SCREW WAS DISASSEMBLED INTO 3 PARTS, NAIL, NUT, AND RING. EVENT DATE: (B)(6) 2019 DATE OF IMPLANT: (B)(6) 2019 DATE OF EXPLANT: (B(6) 2019.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9408037 ↗

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Sources and updates

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