AXSOS 608070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579014), received between Dec 6, 2019 and Dec 6, 2019 — classified as 2 injuries.

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.

• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE TWO AXSOS SCREWS. PRIMARY PROCEDURE, LEFT CUSTOM HEAVY PELVIS. IT WAS REPORTED THAT AFTER IMPLANTING THE REPLACEMENT PELVIS AND TWO AXSOS SCREWS, THE SURGEON NOTICED EXCESSIVE BLEEDING AND HAD TO REMOVE THE DEVICES TO FIND THE SOURCE. THE SURGEON DECIDED TO ABORT THE PROCEDURE AND CLOSED THE PATIENT. POST-OPERATIVELY, THE PATIENT IS STABLE. THE SURGEON REPORTED HIS BELIEF THAT IN REMOVING SCAR TISSUE (PATIENT DIAGNOSED WITH EWINGS SARCOMA AND HAD A PREVIOUS PROCEDURE TO RESECT BONE), HE MAY HAVE HIT A VESSEL WHICH CAUSED THE BLEEDING. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. UPDATE 19/NOV/2019: HOSPITAL RE-STERILIZED THE IMPLANT AND CUT OFF PARTS TO MODIFY FOR THE PATIENT. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY WITH NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury; Perforation of Vessels

  MAUDE report 9421257 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE TWO AXSOS SCREWS. PRIMARY PROCEDURE, LEFT CUSTOM HEAVY PELVIS. IT WAS REPORTED THAT AFTER IMPLANTING THE REPLACEMENT PELVIS AND TWO AXSOS SCREWS, THE SURGEON NOTICED EXCESSIVE BLEEDING AND HAD TO REMOVE THE DEVICES TO FIND THE SOURCE. THE SURGEON DECIDED TO ABORT THE PROCEDURE AND CLOSED THE PATIENT. POST-OPERATIVELY, THE PATIENT IS STABLE. THE SURGEON REPORTED HIS BELIEF THAT IN REMOVING SCAR TISSUE (PATIENT DIAGNOSED WITH EWINGS SARCOMA AND HAD A PREVIOUS PROCEDURE TO RESECT BONE), HE MAY HAVE HIT A VESSEL WHICH CAUSED THE BLEEDING. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. UPDATE 19/NOV/2019: HOSPITAL RE-STERILIZED THE IMPLANT AND CUT OFF PARTS TO MODIFY FOR THE PATIENT. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY WITH NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury; Perforation of Vessels

  MAUDE report 9421255 ↗