N/A 8670087Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TAP 8670087 5.5-6.5 SELF DRILLING · 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 00885074445397), received between Feb 28, 2018 and Feb 28, 2018 — 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 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.
MalfunctionFeb 28, 2018Break; Break
IT WAS REPORTED THAT PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE UNDERWENT LUMBAR DECOMPRESSION AND FUSION(MINIMALLY INVASIVE APPROACH) AT L3-S1. INTRA-OP, TIP OF DRILL TAP BROKE OFF. TAP IMMEDIATELY REMOVED FROM SURGICAL FIELD AND WAS REPLACED WITH ANOTHER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7302980 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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