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NA 72204738Recalls & reported problems

Smith & Nephew, Inc. · T-MAX HEAD POSITIONING SYSTEM REPLACEMENT KIT · 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 00885556537459), received between Dec 29, 2020 and Dec 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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

  • Unstable1

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.

  • MalfunctionDec 29, 2020Unstable; Unstable

    IT WAS REPORTED THAT, THE HEADPIECE OF THE "T-MAX BEACH CHAIR" WAS NOT TIGHTENING DOWN PROPERLY. WHEN THE MEDICAL STAFF TIGHTENED THE BLACK KNOB, THE HEADPIECE WAS STILL LOOSE APPARENTLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11086925 ↗

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