STALIF MIDLINE STM6035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815101029313), received between Aug 18, 2021 and Aug 18, 2021 — classified as 3 deaths.

The most frequently reported specific device problem is “Malposition of Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 18, 2021Malposition of Device; Malposition of Device

  A STALIF M FLX CAGE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021 ALONG WITH 3 STALIF MIDLINE ABO SCREWS. THE CAGE WAS IMPLANTED OFF OF MIDLINE AND ONE OF THE LATERAL SCREWS WAS FOUND TO BE PROTRUDING INTO THE FORAMEN ABOUT 1MM. THIS IS BELIEVED TO HAVE CAUSED THE PATIENT RADICULOPATHY AND LEG PAIN. THE SURGEON DETERMINED THAT THE CAGE AND SCREWS SHOULD BE REVISED TO CORRECT THE POSITIONING. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE ACCESS TO THE TREATED LEVEL TOOK APPROXIMATELY 1 HOUR DUE TO SCAR TISSUE FORMATION. ONCE THE LEVEL WAS EXPOSED, THE SURGEON REMOVED THE 1ST OF 3 SCREWS WITHOUT ANY ISSUES. THE 2ND SCREW WAS REMOVED WITH SOME BLEEDING THAT WAS CONTROLLED. THE PATIENT'S ILIAC VEIN WAS ACROSS THE 3RD SCREW. THE VEIN HAD SCAR TISSUE ADHERENCE AND WAS BLEEDING. THE SURGEONS ATTEMPTED TO CONTROL THE BLEEDING AND MOBILIZE THE VEIN TO REMOVE THE 3RD SCREW; HOWEVER, THE BLEEDING BECAME UNCONTROLLABLE. FOR APPROXIMATELY 3.5 HOURS THE SURGEONS TRIED TO CONTROL THE BLEEDING FROM THE VEIN, BUT THE PATIENT EXPIRED ON THE OPERATING TABLE DUE TO BLOOD LOSS. THE PATIENT DIED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12337988 ↗
• DeathAug 18, 2021Malposition of Device; Malposition of Device

  A STALIF M FLX CAGE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021 ALONG WITH 3 STALIF MIDLINE ABO SCREWS. THE CAGE WAS IMPLANTED OFF OF MIDLINE AND ONE OF THE LATERAL SCREWS WAS FOUND TO BE PROTRUDING INTO THE FORAMEN ABOUT 1MM. THIS IS BELIEVED TO HAVE CAUSED THE PATIENT RADICULOPATHY AND LEG PAIN. THE SURGEON DETERMINED THAT THE CAGE AND SCREWS SHOULD BE REVISED TO CORRECT THE POSITIONING. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE ACCESS TO THE TREATED LEVEL TOOK APPROXIMATELY 1 HOUR DUE TO SCAR TISSUE FORMATION. ONCE THE LEVEL WAS EXPOSED, THE SURGEON REMOVED THE 1ST OF 3 SCREWS WITHOUT ANY ISSUES. THE 2ND SCREW WAS REMOVED WITH SOME BLEEDING THAT WAS CONTROLLED. THE PATIENT'S ILIAC VEIN WAS ACROSS THE 3RD SCREW. THE VEIN HAD SCAR TISSUE ADHERENCE AND WAS BLEEDING. THE SURGEONS ATTEMPTED TO CONTROL THE BLEEDING AND MOBILIZE THE VEIN TO REMOVE THE 3RD SCREW; HOWEVER, THE BLEEDING BECAME UNCONTROLLABLE. FOR APPROXIMATELY 3.5 HOURS THE SURGEONS TRIED TO CONTROL THE BLEEDING FROM THE VEIN, BUT THE PATIENT EXPIRED ON THE OPERATING TABLE DUE TO BLOOD LOSS. THE PATIENT DIED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12337985 ↗
• DeathAug 18, 2021Malposition of Device; Malposition of Device

  A STALIF M FLX CAGE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021 ALONG WITH 3 STALIF MIDLINE ABO SCREWS. THE CAGE WAS IMPLANTED OFF OF MIDLINE AND ONE OF THE LATERAL SCREWS WAS FOUND TO BE PROTRUDING INTO THE FORAMEN ABOUT 1MM. THIS IS BELIEVED TO HAVE CAUSED THE PATIENT RADICULOPATHY AND LEG PAIN. THE SURGEON DETERMINED THAT THE CAGE AND SCREWS SHOULD BE REVISED TO CORRECT THE POSITIONING. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE ACCESS TO THE TREATED LEVEL TOOK APPROXIMATELY 1 HOUR DUE TO SCAR TISSUE FORMATION. ONCE THE LEVEL WAS EXPOSED, THE SURGEON REMOVED THE 1ST OF 3 SCREWS WITHOUT ANY ISSUES. THE 2ND SCREW WAS REMOVED WITH SOME BLEEDING THAT WAS CONTROLLED. THE PATIENT'S ILIAC VEIN WAS ACROSS THE 3RD SCREW. THE VEIN HAD SCAR TISSUE ADHERENCE AND WAS BLEEDING. THE SURGEONS ATTEMPTED TO CONTROL THE BLEEDING AND MOBILIZE THE VEIN TO REMOVE THE 3RD SCREW; HOWEVER, THE BLEEDING BECAME UNCONTROLLABLE. FOR APPROXIMATELY 3.5 HOURS THE SURGEONS TRIED TO CONTROL THE BLEEDING FROM THE VEIN, BUT THE PATIENT EXPIRED ON THE OPERATING TABLE DUE TO BLOOD LOSS. THE PATIENT DIED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12337984 ↗