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Integra® Miltex® 26-2000Recalls & reported problems

Integra Lifesciences Production Corporation · Integra® Miltex® Inge Lamina Spreader 6-1/2" · 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 10381780128410), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

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.

  • MalfunctionJun 21, 2022Mechanical Problem; Mechanical Problem

    A FACILITY REPORTED THAT THE DOCTOR USED THE INGE SPREADER (26-2000) FOR THE FIRST TIME AND THE TENSION RELEASED ON ITS OWN DURING AN UNSPECIFIED PROCEDURE. NO PATIENT INJURY OR DEATH OCCURRED; NO SURGICAL DELAY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14759949 ↗

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) devices

All DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) devices →

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