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N/A 7486113Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSTRUMENT 7486113 LEGACY 6.35 MAS DRIVR · 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 00885074030722), received between Jan 23, 2020 and Jan 23, 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 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.

  • MalfunctionJan 23, 2020Break; Break

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L5-S1 DISC PROTRUSION; AND UNDERWENT DECOMPRESSION AND FUSION AT L5-S1. INTRA-OP, TIP OF THE SCREWDRIVER BROKE AND STUCK IN THE SCREW. THE BROKEN TIP COULD NOT BE REMOVED FROM THE SCREW; HENCE, THE SCREW WAS EXPLANTED AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9620128 ↗

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Sources and updates

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