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N/A 9734716K (UDI 00763000205317)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 00763000205317), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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

  • Material Integrity Problem1

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.

  • MalfunctionNov 16, 2018Material Integrity Problem; Material Integrity Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING THE SELECT PATIENT/ACQUIRE SCANS TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE SHORT SPINOUS PROCESS CLAMP WOULD NOT ENGAGE OR DISENGAGE. THE SITE OPENED ANOTHER SPINE TRAY AND WERE ABLE TO USE THAT CLAMP. PATIENT INFORMATION NOT AVAILABLE AT THE TIME OF THE CALL. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8077322 ↗

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