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N/A 9734716K (UDI 00643169540460)Recalls & reported problems

Medtronic Navigation, Inc. · CLAMP 9734716K SPINOUS PROCESS SHORT KIT · Class 2

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 00643169540460), received between Jan 19, 2017 and Jan 19, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJan 19, 2017Mechanical Problem; Mechanical Problem

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SHORT SPINE CLAMP WAS DAMAGED. THE SCREW WAS NO LONGER TIGHTENING. IT IS NOT KNOWN WHEN THIS ISSUE WAS DISCOVERED. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT. NO PAST PATIENT IMPACT WAS REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 6265169 ↗

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