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N/A 6971265Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSTRUMENT 6971265 IMPLANT TRIAL · 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 00885074309682), received between Aug 11, 2020 and Aug 11, 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.

  • MalfunctionAug 11, 2020Break; Break

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CERVICALE DISCECTOMY FOR PRESTIGE LP SPINAL THERAPY. IT WAS REPORTED THAT THE DISTAL PART OF THE SIZER BREAK DURING INSTRUMENT REMOVAL FROM C5-C6. THE DEVICE WILL BE REPLACED AND WILL BE RETURNED. THERE WERE NO FRAGMENT LEFT INSIDE THE PATIENT AND THERE WERE NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10389622 ↗

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Sources and updates

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