MECTALIF ANTERIOR IMPLANTS 03.30.156Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040727969), received between May 23, 2019 and Dec 12, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryDec 12, 2020Difficult to Remove

  DURING THE PRIMARY SPINE SURGERY, DURING THE FINAL TIGHTENING OF THE SCREWS, THE SURGEON WAS USING THE FINAL TIGHTENER AND ONE OF THE SCREWS CONTINUED TO SPIN INSIDE THE PLATE(THE PLATE DIDN'T HAVE ANY DAMAGE AND THE LOT IS UNAVAILABLE) AFTER BEING SCREWED IN ALL THE WAY. THE SURGEON TRIED TO REMOVE THE SCREW FOR 30 MINUTES AND IT WOULD NOT COME OUT. THE SURGEON LEFT THE SCREW IN THE PLATE SINCE IT WAS SECURE, AND USED THE SAME FINAL TIGHTENER TO TIGHTEN THE OTHER SCREWS (SCREWDRIVER USED AS IN SURGICAL TECHNIQUE RECOMMENDATION). THE SURGERY WAS COMPLETED SUCCESSFULLY AND A CONSIGNMENT SET WAS UTILIZED. THERE WAS NO ISSUE DURING CAGE INSERTION. THE BONE WAS PREPARED ACCORDING TO THE SURGICAL TECHNIQUE, THERE WAS NO BONE DAMAGE. NO ADDITIONAL ANESTHESIA WAS NECESSARY. THE IS NO INFORMATION ON WHICH HOLE OF THE PLATE HAS THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10996071 ↗
• InjuryDec 17, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS INSERTING SCREWS AND DRIVING THE SCREW DOWN WITH THE DRIVER, THE SCREW BROKE. THE SURGEON WAS ABLE TO REMOVE THE HEAD OF THE SCREW, HOWEVER, THE OTHER HALF IS STUCK IN THE PATIENT'S BONE. THERE WAS A 10-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9479948 ↗
• InjuryMay 23, 2019Fracture; Fracture

  THE PATIENT HAD A PRIMARY SPINE SURGERY ON (B)(6) 2018. THE PATIENT REVISED DUE TO PSEUDO-ARTHROSIS AT L5-S1 ON (B)(6) 2019. THE SURGEON REMOVED THE MECTALIF POSTERIOR TIPEEK CAGE AND IMPLANTED A MECTALIF ANTERIOR TIPEEK CAGE AND MECTALIF ANTERIOR CAGE HYBRID 14MM PLATE. UPON INSERTING THE 5X30MM SCREW INTO THE PLATE, THE SCREW BROKE. THE SURGEON WAS ABLE TO REMOVE THE PROXIMAL PORTION OF THE SCREW BUT WAS NOT ABLE TO RETRIEVE THE DISTAL PORTION OF THE SCREW.

  Patient problems: Arthritis

  MAUDE report 8636377 ↗