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MAYFIELD® 439A1092Recalls & reported problems

Integra Lifesciences Corporation · MAYFIELD® XR2 Metal-Free Conversion · Class 2

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 10381780253341), received between Jan 13, 2023 and Jan 13, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionJan 13, 2023Break; Break

    A FACILITY REPORTED THAT THE XR2 METAL-FREE CONVERSION ADAPTOR (439A1092) FORCE APPLICATOR WAS BROKEN DURING OPERATION. NO PATIENT INJURY HAS BEEN REPORTED; HOWEVER, THERE WAS A DELAY OF 30 MINUTES IN SURGERY DUE TO PRODUCT PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16158813 ↗

Other HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices

All HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices →

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