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ENDOSKELETON® TL 7200-1065Recalls & reported problems

Medtronic Sofamor Danek, Inc. · Slap Hammer · 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 00191375009375), received between Oct 3, 2017 and Oct 3, 2017 — 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
  • Detachment Of Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 3, 2017Break; Detachment Of Device Component

    THE SURGEON WAS USING A TRIAL TO SIZE THE PATIENT FOR AN IMPLANT WHEN HE ATTEMPTED TO REMOVE THE INSTRUMENT WITH THE SLAP HAMMER. THE THREADED SHAFT OF THE SLAP HAMMER BROKE OFF WHILE THE SLAP HAMMER ATTACHMENT WAS STILL ATTACHED. AN XLIF PROCEDURE WAS BEING PERFORMED. THERE WERE NO ADVERSE EFFECTS OR HARM TO THE PATIENT AS A RESULT OF THE FAILURE. THE PLANNED PROCEDURE WAS COMPLETED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6911977 ↗

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Sources and updates

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