STALIF MIDLINE STM6025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815101029290), received between Feb 19, 2020 and May 4, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2021Biocompatibility; Osseointegration Problem; Biocompatibility; Osseointegration Problem

  A PATIENT RECEIVED A STALIF MIDLINE II-TI CAGE AND STALIF MIDLINE SCREWS ON (B)(6) 2019. THE ALIF PROCEDURE RESULTED IN A FAILED FUSION AND CONTINUED PATIENT PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADD POSTERIOR FUSION ON AN UNKNOWN DATE. ACCORDING TO THE INFORMATION FROM THE PATIENT, THE SURGEON INFORMED THE PATIENT THAT THE FAILED FUSION MAY BE DUE TO THE PEEK MATERIAL USED TO MAKE THE CAGE. THE PATIENT ALSO SUSPECTS THEY HAVE AN ALLERGY TO METALS USED IN THE IMPLANTS. AS OF THIS REPORT, THE ALLERGY COULD NOT BE CONFIRMED DESPITE THE PATIENT UNDERGOING A IMPLANT MATERIAL ALLERGY PANEL.

  Patient problems: Pain

  MAUDE report 11771870 ↗
• InjuryMay 4, 2021Biocompatibility; Osseointegration Problem; Biocompatibility; Osseointegration Problem

  A PATIENT RECEIVED A STALIF MIDLINE II-TI CAGE AND STALIF MIDLINE SCREWS ON (B)(6) 2019. THE ALIF PROCEDURE RESULTED IN A FAILED FUSION AND CONTINUED PATIENT PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADD POSTERIOR FUSION ON AN UNKNOWN DATE. ACCORDING TO THE INFORMATION FROM THE PATIENT, THE SURGEON INFORMED THE PATIENT THAT THE FAILED FUSION MAY BE DUE TO THE PEEK MATERIAL USED TO MAKE THE CAGE. THE PATIENT ALSO SUSPECTS THEY HAVE AN ALLERGY TO METALS USED IN THE IMPLANTS. AS OF THIS REPORT, THE ALLERGY COULD NOT BE CONFIRMED DESPITE THE PATIENT UNDERGOING A IMPLANT MATERIAL ALLERGY PANEL.

  Patient problems: Pain

  MAUDE report 11771861 ↗
• InjuryMay 4, 2021Biocompatibility; Osseointegration Problem; Biocompatibility; Osseointegration Problem

  A PATIENT RECEIVED A STALIF MIDLINE II-TI CAGE AND STALIF MIDLINE SCREWS ON (B)(6) 2019. THE ALIF PROCEDURE RESULTED IN A FAILED FUSION AND CONTINUED PATIENT PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADD POSTERIOR FUSION ON AN UNKNOWN DATE. ACCORDING TO THE INFORMATION FROM THE PATIENT, THE SURGEON INFORMED THE PATIENT THAT THE FAILED FUSION MAY BE DUE TO THE PEEK MATERIAL USED TO MAKE THE CAGE. THE PATIENT ALSO SUSPECTS THEY HAVE AN ALLERGY TO METALS USED IN THE IMPLANTS. AS OF THIS REPORT, THE ALLERGY COULD NOT BE CONFIRMED DESPITE THE PATIENT UNDERGOING A IMPLANT MATERIAL ALLERGY PANEL.

  Patient problems: Pain

  MAUDE report 11771827 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Migration; Loss of Osseointegration; Device Dislodged or Dislocated; Migration

  A PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2020 TO REMOVE 2 STALIF MIDLINE SCREWS WHICH HAD BACKED OUT OF THE L4-L5 STALIF M FLX CONSTRUCT DUE TO SUBSIDENCE OF THE CAGE INTO THE L5 VERTEBRAE. THE SCREW BACK OUT AND SUBSIDENCE WAS NOTED DURING ROUTINE POST-OPERATIVE FOLLOW-UP ON (B)(6) 2020. THE SURGEON ELECTED TO REMOVE THE SCREWS DUE TO THE AGGRESSIVE SCREW BACK OUT AND LOCATION TO BLOOD VESSELS TO PRECLUDE SERIOUS INJURY. IN ADDITION TO THE SCREW REMOVAL, POSTERIOR FIXATION WAS ADDED TO STABILIZE THE IMPLANT. THE PATIENT DID NOT PRESENT WITH ANY SIGNS OR SYMPTOMS RELATED TO THE SCREW BACK OUT AT THE FOLLOW-UP APPOINTMENT.

  Patient problems: Spinal Column Injury

  MAUDE report 9729217 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Migration; Loss of Osseointegration; Device Dislodged or Dislocated; Migration

  A PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2020 TO REMOVE 2 STALIF MIDLINE SCREWS WHICH HAD BACKED OUT OF THE L4-L5 STALIF M FLX CONSTRUCT DUE TO SUBSIDENCE OF THE CAGE INTO THE L5 VERTEBRAE. THE SCREW BACK OUT AND SUBSIDENCE WAS NOTED DURING ROUTINE POST-OPERATIVE FOLLOW-UP ON (B)(6) 2020. THE SURGEON ELECTED TO REMOVE THE SCREWS DUE TO THE AGGRESSIVE SCREW BACK OUT AND LOCATION TO BLOOD VESSELS TO PRECLUDE SERIOUS INJURY. IN ADDITION TO THE SCREW REMOVAL, POSTERIOR FIXATION WAS ADDED TO STABILIZE THE IMPLANT. THE PATIENT DID NOT PRESENT WITH ANY SIGNS OR SYMPTOMS RELATED TO THE SCREW BACK OUT AT THE FOLLOW-UP APPOINTMENT.

  Patient problems: Spinal Column Injury

  MAUDE report 9729216 ↗