N/A 8616001Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INST 8616001 DUALPURPOSE NUTDRVR COLO II · 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 00673978064628), received between Aug 12, 2020 and Aug 12, 2020 — 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionAug 12, 2020Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER FOR CORRECTION AND FIXATION TO TREAT AIS (ADOLESCENT IDIOPATHIC SCOLIOSIS). IT WAS REPORTED THAT CORRECTION AND FIXATION WERE PERFORMED TO TREAT AIS. THE NUT WAS TIGHTENED DURING ROD PLACING AND CORRECTION . AT THAT TIME, THE TIP OF THE DRIVER WAS BROKEN. THE NUT GRIPPING PART IS MADE UP OF SMALL PARTS, AND IT SEEMS THAT THE SCREW THAT HOLDS IT CAME OFF. IT IS ESSENTIAL TO CHECK THIS SCREW FOR BREAKING (WHETHER THERE ARE FRAGMENTS REMAINED). THE PRE-OP DIAGNOSIS WAS ADOLESCENT IDIOPATHIC SCOLIOSIS. LEVELS IMPLANTED WERE T5-T12. THE SALES REP HAS NOT RECEIVED ANY CONTACT THAT THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE INSTRUMENT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WAS NO IN- PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. THE PRODUCT WILL BE REPLACED BY A MEDTRONIC PRODUCT IN THE FUTURE. NO FURTHER COMPLICATIONS REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10395023 ↗
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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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