Mectalif Posterior 03.27.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030831485), received between Jan 9, 2019 and Apr 29, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2020Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  PLIF SURGERY WAS PERFORMED AT L4-L5 ON (B)(6) 2020. THE SURGEON DISCOVERED AT X-RAYS THAT THE ONE CAGE WAS BACKED OUT AND ANOTHER WAS ROTATED BETWEEN THE VERTEBRAL BODY SPACE. REVISION SURGERY WAS PERFORMED ON MARCH 30 (26 DAYS AFTER PRIMARY SURGERY). THE SURGEON REMOVED BOTH CAGES AND INSERTED THE MECTALIF OBLIQUE CAGE H9 X L5°. THE SURGEON DISCOVERED THE LOOSENING OF THE PEDICLE SCREW AT L5, SO THE SURGEON REPLACED THE 7MM PEDICLE SCREW WITH THE 7.5MM PEDICLE SCREW. PEDICLE SCREWS WERE NOT MEDACTA'S.

  Patient problems: No Code Available

  MAUDE report 10008595 ↗
• InjuryApr 1, 2020Device Dislodged or Dislocated

  THE SURGEON INSERTED THE TRIAL CAGE TO CHECK THE SIZE OF THE CAGE, INSERTED THE 2 CAGES INTO THE PATIENT DISC SPACE T11/T12, AND PERFORMED THE COMPRESSION. AFTER THAT THE SURGEON DISCOVERED THE BACK OUT OF THE CAGE DURING THE POST OPERATIVE FINAL CHECK. REVISION SURGERY PERFORMED THE SAME DAY OF PRIMARY SURGERY AND THE SURGEON TRIED TO INSERT THE 2 CAGES AGAIN, BUT IT WAS NOT POSSIBLE. FINALLY 2 CAGES WERE REPLACED WITH COMPETITORS DEVICES. COMPETITOR'S PEDICLE SCREWS AND RODS WERE USED.

  Patient problems: No Code Available

  MAUDE report 9909847 ↗
• InjuryFeb 25, 2020Device Slipped

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PLIF SURGERY WAS PERFORMED AT L3-S1. THE SURGEON DISCOVERED THE BACKOUT OF THE CAGE AT LEFT SIDE OF L5. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGEON REMOVED THE CAGE ONLY AT LEFT SIDE OF L5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9750253 ↗
• MalfunctionJul 12, 2019Material Deformation; Material Deformation

  THE SURGEON WAS NOT ABLE TO ENGAGE STRAIGHTLY THE MECTALIF TIPEEK POSTERIOR CAGE . THREAD OF THE CAGE SEEMED TO BE DEFORMED. BACKUP IMPLANT WAS USED FOR THE ALTERNATIVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784958 ↗
• MalfunctionJan 9, 2019Connection Problem

  THE NURSE WAS NOT ABLE TO ENGAGE THE CAGE WITH THE INSERTER STRAIGHT. THE SURGERY WAS FINISHED WITH THE BACK UP IMPLANT. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 5 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8230881 ↗