Aero-AL 48922214Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327067613), received between Oct 11, 2016 and Oct 11, 2016 — 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 16, 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.

• MalfunctionOct 11, 2016Bent; Difficult to Insert; Failure to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE ANCHOR (SUPERIOR PATIENT LEFT ANCHOR). DURING INSERTION OF THE ANCHOR INTO THE CUT TRACK, IT WENT INTO THE DEVICE AND LOCKED INTO THE IMPLANT, HOWEVER IT SKIVED OFF THE ENDPLATE AND DID NOT GO INTO THE VERTEBRAL BODY. THE ENTIRE IMPLANT WAS THEN REMOVED. SECOND ATTEMPT WITH A NEW IMPLANT SAME SIZE; ALL 3 OTHER ANCHORS WERE INSERTED SUCCESSFULLY. THE SUPERIOR ANCHOR WAS LEFT FOR LAST, SURGEON HAD THE SAME ISSUE. UPON INSERTION OF THE ANCHOR HE COULD NOT GET THE ANCHOR TO ADVANCE ALL THE WAY. HE THEN REMOVED THE INSERTION GUIDE AND TRIED TO FREEHAND TAMP THE ANCHOR AND THE ANTERIOR ASPECT OF THE DEVICE BENT. 3MM OF THE ANCHOR WAS PROTRUDING ANTERIORLY TO OF THE DEVICE. SURGEON DID NOT WANT TO REMOVE THE ENTIRE DEVICE AND THEREFORE DECIDED TO USE A METAL CUTTING BURR TO GRIND AWAY PROTRUDING ANCHOR, LEAVING THE MAJORITY OF THE ANCHOR IN THE PATIENT. ALL 3 OTHER ANCHORS WENT THROUGH EASILY, THE PATIENT'S BONE QUALITY WAS VERY HARD AT THE SPECIFIC REGION WHERE THE 4TH ANCHOR WOULD NOT GO IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6018852 ↗
• MalfunctionOct 11, 2016Material Deformation; Material Integrity Problem; Bent; Difficult to Insert; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE ANCHOR (SUPERIOR PATIENT LEFT ANCHOR). DURING INSERTION OF THE ANCHOR INTO THE CUT TRACK, IT WENT INTO THE DEVICE AND LOCKED INTO THE IMPLANT, HOWEVER IT SKIVED OFF THE ENDPLATE AND DID NOT GO INTO THE VERTEBRAL BODY. THE ENTIRE IMPLANT WAS THEN REMOVED. SECOND ATTEMPT WITH A NEW IMPLANT SAME SIZE; ALL 3 OTHER ANCHORS WERE INSERTED SUCCESSFULLY. THE SUPERIOR ANCHOR WAS LEFT FOR LAST, SURGEON HAD THE SAME ISSUE. UPON INSERTION OF THE ANCHOR HE COULD NOT GET THE ANCHOR TO ADVANCE ALL THE WAY. HE THEN REMOVED THE INSERTION GUIDE AND TRIED TO FREEHAND TAMP THE ANCHOR AND THE ANTERIOR ASPECT OF THE DEVICE BENT. THREE MM OF THE ANCHOR WAS PROTRUDING ANTERIORLY TO OF THE DEVICE. SURGEON DID NOT WANT TO REMOVE THE ENTIRE DEVICE AND THEREFORE DECIDED TO USE A METAL CUTTING BURR TO GRIND AWAY PROTRUDING ANCHOR, LEAVING THE MAJORITY OF THE ANCHOR IN THE PATIENT. ALL 3 OTHER ANCHORS WENT THROUGH EASILY, THE PATIENT'S BONE QUALITY WAS VERY HARD AT THE SPECIFIC REGION WHERE THE 4TH ANCHOR WOULD NOT GO IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6018851 ↗