coflex Interlaminar Technology, 8mm UQI00008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260148898501), received between Nov 15, 2023 and Jun 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Expiration Date Error; Expiration Date Error

  THE MANUFACTURER WAS MADE AWARE OF A MEDICAL DEVICE THAT WAS UTILIZED BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGING ON 05/27/2025. A PRODUCT USAGE FORM WAS SUBMITTED TO THE MANUFACTURER WHICH IDENTIFIED A MEDICAL DEVICE LOT THAT HAD SURPASSED THE EXPIRATION DATE. THE MEDICAL DEVICE HAD A DOCUMENTED EXPIRATION DATE OF 06/10/2024 AND WAS IMPLANTED ON (B)(6) 2024. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY ASSOCIATED WITH THIS PRODUCT COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332608 ↗
• MalfunctionNov 15, 2023Expiration Date Error; Expiration Date Error

  THE MANUFACTURER WAS MADE AWARE OF A MEDICAL DEVICE IMPLANT THAT WAS IMPLANTED AFTER THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINANT AND SURGICAL FACILITY INQUIRED ABOUT THE POSSIBILITY OF EXPIRATION DATE EXTENSION OF THE IMPLANTED DEVICE, WHICH WAS NOT SUPPORTED BY THE PACKAGING VALIDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142095 ↗