Aero-AL 48921100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327273496), received between Feb 16, 2016 and Dec 8, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE AERO AL INSERTER INNER SHAFT FRACTURED INTO THE AERO AL CAGE DURING IMPLANT INSERTION. THE TIP OF THE INNER SHAFT WAS LEFT IN THE CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD CAPTURES THE AERO AL INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962536 ↗
• MalfunctionSep 21, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCRUB TECH LOADED A 15 CAGE ONTO A 19 INSERTER AND AS A RESULT, THE PRESSURE FROM TAMPING AN ANCHOR IN BROKE 2 INSERTER GUIDE PIN. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898484 ↗
• MalfunctionSep 21, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCRUB TECH LOADED A 15 CAGE ONTO A 19 INSERTER AND AS A RESULT, THE PRESSURE FROM TAMPING AN ANCHOR IN BROKE 2 INSERTER GUIDE PIN. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898460 ↗
• MalfunctionJun 13, 2018Break; Detachment Of Device Component; Fracture; Fracture

  IT IS REPORTED THAT DOCTOR INITIALLY INSERTED IMPLANT ON THE INSERTER INTO THE PATIENT. THE DOCTOR WAS NOT SATISFIED WITH THE PLACEMENT OF THE INTERBODY AND WAS MOVING THE IMPLANT ON THE INSERTER SIDE TO SIDE TO MOVE IT MORE MEDIAL. WHEN HE WAS DOING THIS, THE TIP OF THE DRAW ROD BROKE OFF INTO THE IMPLANT. HE WAS ABLE TO RETRIEVE THE DRAW ROD AND TIP. THE SECOND DRAW ROD WAS USED TO RENGAGE THE INSERTER ON TOP OF THE IMPLANT AND THE PROCEDURE CONTINUED WITH NO ISSUES. NO ADVERSE CONSEQUENCES TO PATIENT OR SURGICAL DELAY IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598084 ↗
• MalfunctionFeb 21, 2018Fracture; Break; Fracture

  IT IS REPORTED THAT DURING THE PROCEDURE WHILE PUTTING IN THE CAGE AND BLADES, THE DRAW ROD BROKE INSIDE THE CAGE WHEN THE SURGEON TRIED TO DISENGAGE THE DRAW ROD. ANOTHER INSTRUMENT WAS USED TO REMOVE THE ROD. THERE WERE NO FRAGMENTS, NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287470 ↗
• MalfunctionJan 19, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; ON THE SPECIFIED DATE, (B)(6) 2017, THE SYSTEM WAS BEING USED IN A 2 LEVEL ALIF PROCEDURE. ONE CAGE HAD ALREADY BEEN IMPLANTED AT THE 5/1 LEVEL. THE SECOND CAGE WAS BEING IMPLANTED AT THE 4/5 LEVEL, AND THE INSTRUMENT "INSERTER GUIDE INNER SHAFT BROKE AT THE JUNCTION OF THE FINGER TIGHTENING CYLINDER AND THE DRAW ROD THAT INSERTS INTO THE CAGE INSERTER/GUIDE, DURING MALLETING IN OF THE CAGE INTO THE DISK SPACE. THERE WAS A SECOND INSTRUMENT, IN THE INSTRUMENT TRAY, AND THAT WAS USED TO COMPLETE THE INSERTION OF THE CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7206278 ↗
• MalfunctionAug 11, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT IS REPORTED THAT THE INSERTER SHAFT BROKE AT THE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787605 ↗
• MalfunctionMay 9, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; THE INSERTER GUIDE INNER SHAFT BROKE AFTER MALLETING THE CAGE INTO THE DISC SPACE. PLATE WAS USED SINCE THE INSERTER WAS NOT ATTACHED TO DELIVER THE ANCHORS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553730 ↗
• MalfunctionJan 27, 2017Break; Detachment Of Device Component; Fracture; Material Fragmentation; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGERY WHILE THE SURGEON WAS REMOVING THE INSERTER FROM THE IMPLANT, THE INSERTER INNER SHAFT TIP BROKE OFF. ALL BROKEN FRAGMENTS WERE REMOVED. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6282783 ↗
• MalfunctionNov 18, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT WHILE MALLETING THE CAGE THE THREADS OF THE INSERTER GUIDE INNER SHAFT BROKE. THEY WERE ABLE TO BE REMOVED FROM THE CAGE AND THE SECOND INSERTER GUIDE INNER SHAFT WAS USED TO FINISH TH PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6112866 ↗
• MalfunctionOct 3, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT UPON INSERTION OF A TRIAL, INSERTER INSIDE SHAFT AND TRIAL BROKE. ADDITIONAL NOTE: TWO OF BLADES DID NOT GO INTO THE CAGE AND ARE IMBEDDED IN THE BONE DUE TO THE INSERTER INSDE SHAFT BREAKING.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 5995384 ↗
• MalfunctionMay 23, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; INSERTER GUIDE INNER SHAFT BROKE DURING SURGERY. IT BROKE WHEN THE SHAFT WAS BEING INSERTED INTO IMPLANT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5673057 ↗
• MalfunctionFeb 16, 2016Mechanical Jam; Break; Difficult to Remove; Sticking; Failure to Advance; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING THE CASE THE BOTTOM LEFT ANCHOR GOT STUCK IN THE INSERTER AND WOULD NOT ADVANCE INTO THE BONE AND DEFORMED SIGNIFICANTLY. OSTEOPHYTES WERE PRESENT AND THE PILOT CUTTER WAS USED. THE CUTTER TIP WAS VISIBLY DAMAGED.IT WAS INCREDIBLY DIFFICULT TO UNTHREAD THE INSIDE SHAFT TO REMOVE THE INSERTER FROM THE CAGE. THE DAMAGED ANCHOR WAS RETRIEVED AND THE CASE WAS COMPLETED WITH 3 ANCHORS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5439371 ↗