Mectalif Oblique 03.26.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030830631), received between Mar 22, 2019 and Sep 11, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2020Loose or Intermittent Connection; Device Dislodged or Dislocated

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. TLIF SURGERY WAS PERFORMED WITH THE MECTALIF OBLIQUE CAGE AND COMPETITOR'S PEDICLE SCREWS AT L3-L5. PEDICLE SCREW 7MM WAS INSERTED INTO THE L3-L5, AND THE MECTALIF OBLIQUE CAGE H10MM WAS INSERTED INTO THE L3-L5, AND THE MECTALIF OBLIQUE CAGE H9MM WAS INSERTED INTO THE L4-L5. 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON DISCOVERED THE BACK OUT OF THE MECTALIF OBLIQUE CAGE AND THE LOOSENING OF THE PEDICLE SCREW AT L4-L5 BY CT SCAN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 (1 MONTH AFTER PRIMARY SURGERY). THE SURGEON REPLACED WITH THE ONE MORE BIGGER SIZE WITH THE ALL PEDICLE SCREWS. THE SURGEON REMOVED THE MECTALIF OBLIQUE CAGE H9M FROM THE PATIENT VERTEBRA, AND INSERTED THE MECTALIF OBLIQUE CAGE 12X28X12 L5°. THE SURGEON IMPACTED THE MECTALIF OBLIQUE CAGE WITH THE HAMMER IN ORDER NOT TO BE BACK OUT AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 10519959 ↗
• InjuryDec 4, 2019Migration; Migration

  THE SURGEON DISCOVERED THE BACK OUT OF THE OBLIQUE INTERBODY FUSION DEVICE PEEK/TI AT L5-S1. THE PATIENT HAD 2 SURGERIES BEFORE. THIS IS THE SECOND EXPERIENCE OF THE BACK OUT FOR THE SAME PATIENT. THE FIRST SURGERY DATE IS UNKNOWN. THE SECOND SURGERY WAS PERFORMED ON AUGUST 23. NO ADDITIONAL INFO IS AVAILABLE AT THE MOMENT. THE SURGEON SUCCESSFULLY REVISED THE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9408357 ↗
• MalfunctionMar 22, 2019Difficult to Insert

  THE NURSE WAS NOT ABLE TO INSERT THE CAGE STRAIGHT WITH THE HANDLE. THE SURGERY WAS FINISHED WITH A BACK UP IMPLANT. 5 MINUTES OF DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443624 ↗