Aero-LL 48940045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327066203), received between Jan 6, 2017 and Jan 6, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionJan 6, 2017Bent; Fracture; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; SURGERY TYPE: L3-4 & L2-3 LATERAL INTERBODY FUSION ALL ISSUES OCCURRED AT L3-4 LEVEL WHICH WAS PERFORMED FIRST. SECOND LEVEL (L2-3) WENT AS EXPECTED WITHOUT ANY COMPLICATIONS. DURING INSERTION OF PILOT CUTTER THE TIP OF THE CUTTER WAS DEFORMED (BENT UPWARD) AS THE CUTTER WAS DRIVEN FORWARD INTO THE SIDE OF THE VERTEBRAL BODY. DURING INSERTION OF THE 1ST AND 2ND BLADES OF THE DEVICE BLADES DEFORMED (LEADING EDGE BENT UPWARD AND THE TOP PART OF THE BLADE SHEARED COMPLETELY RESULTING IN BLADE FRACTURE). THE SUPERIOR BLADE WAS LEFT IN BONE IN ITS FRACTURED STATE (REMOVAL WAS NOT POSSIBLE). THE INFERIOR BLADE WAS REMOVED AFTER OBSERVING SIGNIFICANT DEFORMATION OF THE BLADE PRIOR TO COMPLETE INSERTION. THE SURGICAL DELAY ASSOCIATED WITH BLADE REMOVAL AND TROUBLESHOOTING WAS APPROXIMATELY 30 MINUTES. ADDITIONALLY, HAVING 1 PILOT CUTTER IN THE NATIONAL LOANERS SET DOES NOT ALLOW FOR ANY BACK-UP INSTRUMENTATION TO COMPLETE THE SURGERY. THIS IS AN EASILY IDENTIFIABLE INVENTORY ISSUE THAT COMPOUNDED THE INITIAL PRODUCT RELATED ISSUE. FLUOROSCOPIC IMAGES SHOWING PROGRESSION OF PILOT CUTTER DEFORMATION AND BLADE/ANCHOR DEFORMATION AND FRACTURE ARE AVAILABLE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6230961 ↗
• MalfunctionJan 6, 2017Bent; Fracture; Material Deformation; Material Deformation

  IT WAS REPORTED THAT; SURGERY TYPE: L3-4 & L2-3 LATERAL INTERBODY FUSION ALL ISSUES OCCURRED AT L3-4 LEVEL WHICH WAS PERFORMED FIRST. 2ND LEVEL (L2-3) WENT AS EXPECTED WITHOUT ANY COMPLICATIONS. DURING INSERTION OF PILOT CUTTER THE TIP OF THE CUTTER WAS DEFORMED (BENT UPWARD) AS THE CUTTER WAS DRIVEN FORWARD INTO THE SIDE OF THE VERTEBRAL BODY. DURING INSERTION OF THE 1ST AND 2ND BLADES OF THE DEVICE BLADES DEFORMED (LEADING EDGE BENT UPWARD AND THE TOP PART OF THE BLADE SHEARED COMPLETELY RESULTING IN BLADE FRACTURE). THE SUPERIOR BLADE WAS LEFT IN BONE IN ITS FRACTURED STATE (REMOVAL WAS NOT POSSIBLE). THE INFERIOR BLADE WAS REMOVED AFTER OBSERVING SIGNIFICANT DEFORMATION OF THE BLADE PRIOR TO COMPLETE INSERTION. THE SURGICAL DELAY ASSOCIATED WITH BLADE REMOVAL AND TROUBLESHOOTING WAS APPROXIMATELY 30 MINUTES. ADDITIONALLY, HAVING 1 PILOT CUTTER IN THE NATIONAL LOANERS SET DOES NOT ALLOW FOR ANY BACK-UP INSTRUMENTATION TO COMPLETE THE SURGERY. THIS IS AN EASILY IDENTIFIABLE INVENTORY ISSUE THAT COMPOUNDED THE INITIAL PRODUCT RELATED ISSUE. FLUOROSCOPIC IMAGES SHOWING PROGRESSION OF PILOT CUTTER DEFORMATION AND BLADE/ANCHOR DEFORMATION AND FRACTURE ARE AVAILABLE,

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6230957 ↗