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NA 9734716KRecalls & 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 00643169936324), received between Jun 6, 2018 and Jun 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1

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.

  • MalfunctionJun 6, 2018Material Deformation; Material Deformation

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A MAST/PERC SPINAL FUSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHILE SETTING UP EQUIPMENT. THE SHORT HEX SCREW SPINOUS PROCESS CLAMP WOULD CLOSE WHEN THE CLAMP WAS HELD IN THE AIR, BUT NOT WHEN POSITIONED AROUND A SPINOUS PROCESS. SURGERY WAS COMPLETED USING THE NAVIGATION SYSTEM AND A DIFFERENT SET OF SPINOUS PROCESS CLAMPS. SURGICAL TIME WAS EXTENDED BY LESS THAN ONE HOUR AND THERE WAS NO REPORTED PATIENT IMPACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7573696 ↗

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