Mectalif Posterior 03.27.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030831676), received between Jul 25, 2017 and Sep 13, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjurySep 13, 2018Break; Break

  THE SURGEON TRIED TO INSERT THE POSTERIOR CAGE OBLIQUELY BECAUSE THE PATIENT'S VERTEBRAL BODY WAS TOO SMALL AGAINST THE LENGTH OF THE CAGE. WHEN THE SURGEON WAS INSERTING THE POSTERIOR CAGE OBLIQUELY, THE POSTERIOR CAGE WAS BROKEN. THE SURGEON REMOVED THE BROKEN POSTERIOR CAGE AND INSERTED THE BACKUP POSTERIOR CAGE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7872483 ↗
• MalfunctionJul 25, 2017Break; Break

  THE EVENT OCCURRED DURING A POSTERIOR FUSION ON 2 LEVELS(LEVELS INVOLVED: L4, L5, S1). ON THE LEVEL L5-S1, THE SURGEON USED THE 11X25X9 L10° CAGE. THE SPACE WAS NARROWER THAN THE LEVEL L4-L5 WHERE HE USED 11X25X11 L5° CAGES. ON THE RIGHT SIDE, THE SURGEON COULD PLACE THE 11X25X9 L10° CAGE WITHOUT PROBLEM, ON THE OTHER HAND ON THE LEFT SIDE IT SEEMED THE SPACE WAS A BIT NARROWER THAN THE RIDE SIDE (UNI-LATERAL COLLAPSE). THE SURGEON PUT THE CAGE ON THE POSITION HE LIKED AND TRIED TO HAMMER IT IN. PROBABLY HE TURNED WITH THE HANDLE TO GIVE THE RIGHT DIRECTION DUE TO THE NARROW SPACE AND THEN USED THE HAMMER TO INSERT. AFTER THIS MANEUVER HE FELT THAT THERE WAS SOME TOGGLE BETWEEN CAGE AND HOLDER. THERE WAS A "CRACK" ON THE POSTERIOR WALL OF THE CAGE. THERE WHERE ALSO SOME COATING FRAGMENTS MISSING OF THE CAGE. THE MAJOR PROBLEM WAS THAT THERE WAS NO EXTRA STOCK TO USE THE SAME CAGE FOR REPLACEMENT OF THE DAMAGED ONE. SO THE SURGEON WAS FORCED TO USE THE 11X25X9 L5° CAGE. THE RESULT WAS AN ASYMMETRICALLY CAGE PLACEMENT. THE SURGERY HAS BEEN DELAYED ABOUT 5MIN. THE SURGEON WAS A LITTLE BIT UN-SATISFIED BECAUSE THERE WAS NO EXTRA CAGE DUE THE LIMITED STOCK OF THE 10° CAGES OF 9 MM.

  Patient problems: No Information

  MAUDE report 6740092 ↗