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