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TSI AL-0110Recalls & reported problems

Tedan Surgical Innovations, L.L.C. · ACCESSORY ARM · Class 1

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 00843059100983), received between Jul 8, 2021 and Jul 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 8, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED TO THE DISTRIBUTOR, THAT WHILE THE PROCEDURE WAS TAKING PLACE, A SCREW BROKE INTO 2 WHILE THE ARM WAS INSTALLED PROPERLY. ONE OF THE TWO PARTS "PROJECTED" AND HIT AN OR PERSONNEL IN THE HEAD AND FELL (TRANSLATED FROM FRENCH).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12137439 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.