N/A 9870010Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 9870010 FLEXIBLE HEX 3.2MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00613994284952), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER FOUND BROKEN. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT UPON THE SEPTIC TO STERILIZE FOR KCS WOULD NOT STERILIZE IT BECAUSE IT WAS BROKEN. THEY REMOVED IT FROM THE TRAY AND TURNED IT OVER TO THE FOLLOWING DAY. COMES OUT OF PYRAMID TRAY FOR ALIFS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19635253 ↗
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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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