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MAYFIELD® A2101PRecalls & reported problems

Integra Lifesciences Corporation · POOL - MAYFIELD ULTRA BASE UNIT · 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 10381780268000), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

  • Device Slipped1

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.

  • MalfunctionMar 31, 2022Device Slipped; Device Slipped

    A FACILITY REPORTED THAT A PATIENT IN HIS 30'S WAS PREPPED FOR A CERVICAL SPINE PROCEDURE, AND THE MAYFIELD ULTRA BASE UNIT LOANER (A2101) SLIPPED AT THE MAIN CLAMP. THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER THERE WAS NO INJURY NOR DELAY TO SURGERY. THE PROCEDURE WAS COMPLETED USING THE SAME UNIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13966017 ↗

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