Aero-LL 48940050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327066173), received between Mar 25, 2019 and Mar 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE ANCHOR WAS DAMAGED(BENT UPWARD) WHILE INSERTING AT L3 VERTEBRAE. THE SURGEON REMOVED THE ANCHOR AND TRIED USING SECOND ANCHOR WHICH WAS DEFORMED AGAIN. THE SURGEON DECIDED NOT TO PLACE BLADE ON THE SUPERIOR LEVEL. THE SURGEON WAS CONTENT WITH THE AMOUNT OF FIXATION AND COMPLETED SURGERY SUCCESSFULLY (FACET FUSION WITH MICRO DECOMPRESSION ON THE POSTERIOR SIDE) USING ANOTHER ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONCRETE BONE QUALITY AND THE SURGEON ATTRIBUTED MUCH OF EVENT TO THE BONE QUALITY OF THE PATIENT. A SURGICAL DELAY OF CLOSE TO AN HOUR WAS REPORTED. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8447952 ↗
• MalfunctionMar 25, 2019Material Deformation; No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE ANCHOR WAS DAMAGED(BENT UPWARD) WHILE INSERTING AT L3 VERTEBRAE. THE SURGEON REMOVED THE ANCHOR AND TRIED USING SECOND ANCHOR WHICH WAS DEFORMED AGAIN. THE SURGEON DECIDED NOT TO PLACE BLADE ON THE SUPERIOR LEVEL. THE SURGEON WAS CONTENT WITH THE AMOUNT OF FIXATION AND COMPLETED SURGERY SUCCESSFULLY (FACET FUSION WITH MICRO DECOMPRESSION ON THE POSTERIOR SIDE) USING ANOTHER ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONCRETE BONE QUALITY AND THE SURGEON ATTRIBUTED MUCH OF EVENT TO THE BONE QUALITY OF THE PATIENT. A SURGICAL DELAY OF CLOSE TO AN HOUR WAS REPORTED. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

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

  MAUDE report 8447890 ↗