NA 9734715KRecalls & reported problems
Medtronic Navigation, Inc. · CLAMP 9734715K SPINOUS PROCESS TALL KIT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169936317), received between Jun 5, 2018 and Jun 5, 2018 — classified as 2 malfunctions.
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
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 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 TALL 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 7571775 ↗MalfunctionJun 5, 2018Break; Break
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT AN ORTHOPEDIC STEREOTACTIC INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 7569447 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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