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N/A 9730820Recalls & reported problems

Medtronic Navigation, Inc. · AWL 9730820 TACTILE · 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 00721902984433), received between Jun 2, 2017 and Jun 2, 2017 — 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 Consequences Or Impact 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 2, 2017Material Deformation; Material Deformation

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE AWL BECAME BENT WENT ATTEMPTING TO HAMMER DOWN FOR PEDICLE ACCESS ON THE FINAL SCREW PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6607605 ↗

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