Apache 1 (REF GAC-LG)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GACLG0), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Improper or Incorrect Procedure or Method; Loosening of Implant Not Related to Bone-Ingrowth; Improper or Incorrect Procedure or Method; Loosening of Implant Not Related to Bone-Ingrowth

  ON JUNE 20, 2024 THE REPRESENTATIVE FOR VSI SURGICAL INFORMED GENESYS SPINE VIA TEXT MESSAGE THAT DURING A FOLLOW-UP APPOINTMENT, AN ANCHOR WAS FOUND TO HAVE BACKED OUT OF THE 3DP AIS-C II INTERBODY. THE DOCTOR PLANNED TO PERFORM A REVISION ON (B)(6) 2024 AND THE REPRESENTATIVE WOULD INFORM GENESYS SPINE ON THE RESULTS POST OP PHOTOS FOLLOWING SURGERY AND PHOTOS TAKEN DURING THE FOLLOW-UP APPOINTMENT WERE RECEIVED. ON JUNE 24, 2024 THE REPRESENTATIVE FOR VSI SURGICAL INFORMED GENESYS SPINE THAT THE REVISION PROCEDURE WAS COMPLETED ON (B)(6), 2024, RESULTING IN THE LOOSE ANCHOR BEING EXTRACTED. THE REPRESENTATIVE WAS NOT ABLE TO RETRIEVE THE EXTRACTED ANCHOR TO SEND TO GENESYS SPINE FOR INSPECTION. GENESYS SPINE WAS MADE AWARE OF THE REVISION TO EXPLANT THE ANCHOR ON (B)(6), 2024.

  Patient problems: Failure of Implant

  MAUDE report 19820555 ↗