MIDLINE II-Ti M391712cRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815101021713), received between Feb 6, 2017 and Feb 6, 2017 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2-LEVEL ALIF AT L4-5 AND L5-S1 WAS PERFORMED ON THE PATIENT ON (B)(6) 2016. THEY BROUGHT THE PATIENT BACK TO THE OR TO TREAT AN INFECTION THEY HAD DETERMINED WAS SOMEWHERE INTERNAL NEAR THE L4-5 INTERBODY AREA. UPON EXPLORATION, THEY FOUND AN INFECTED AREA TRANS-PSOAS IN THAT AREA THAT ALSO EXTENDED INTO THE INTERBODY AREA WHERE THE CAGE WAS PLACED. THEY REMOVED THE SCREWS AND THE CAGE AND DISCOVERED THAT THE INFECTION HAD FOUND IT'S WAY INTO THE DISC SPACE, DISSOLVED THE BONE GRAFT MATERIAL AND LOOSENED THE INTERFACE BETWEEN THE CAGE AND THE ENDPLATES. ONE OF THE ENDPLATES APPEARED TO BE FRACTURED, SO THE SURGEON DECIDED NOT TO REPLACE THE CAGE, AND INSTEAD TO THOROUGHLY CLEAN AND WASH THE AREA, PACK THE DISC SPACE WITH CANCELLOUS CHIPS AND OTHER BONE GRAFT MATERIAL AND COME BACK LATER WITH POSTERIOR PEDICLE SCREWS TO STABILIZE THE JOINT. THE DO NOT THINK THE INFECTION IS DEVICE RELATED, BUT IT IS NOT KNOWN WHAT CAUSED THE INFECTION OR WHERE IT ORIGINATED.

  Patient problems: Unspecified Infection

  MAUDE report 6304108 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2-LEVEL ALIF AT L4-5 AND L5-S1 WAS PERFORMED ON THE PATIENT ON (B)(6) 2016. THEY BROUGHT THE PATIENT BACK TO THE OR TO TREAT AN INFECTION THEY HAD DETERMINED WAS SOMEWHERE INTERNAL NEAR THE L4-5 INTERBODY AREA. UPON EXPLORATION, THEY FOUND AN INFECTED AREA TRANS-PSOAS IN THAT AREA THAT ALSO EXTENDED INTO THE INTERBODY AREA WHERE THE CAGE WAS PLACED. THEY REMOVED THE SCREWS AND THE CAGE AND DISCOVERED THAT THE INFECTION HAD FOUND IT'S WAY INTO THE DISC SPACE, DISSOLVED THE BONE GRAFT MATERIAL AND LOOSENED THE INTERFACE BETWEEN THE CAGE AND THE ENDPLATES. ONE OF THE ENDPLATES APPEARED TO BE FRACTURED, SO THE SURGEON DECIDED NOT TO REPLACE THE CAGE, AND INSTEAD TO THOROUGHLY CLEAN AND WASH THE AREA, PACK THE DISC SPACE WITH CANCELLOUS CHIPS AND OTHER BONE GRAFT MATERIAL AND COME BACK LATER WITH POSTERIOR PEDICLE SCREWS TO STABILIZE THE JOINT. THE DO NOT THINK THE INFECTION IS DEVICE RELATED, BUT IT IS NOT KNOWN WHAT CAUSED THE INFECTION OR WHERE IT ORIGINATED.

  Patient problems: Unspecified Infection

  MAUDE report 6304105 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2-LEVEL ALIF AT L4-5 AND L5-S1 WAS PERFORMED ON THE PATIENT ON (B)(6) 2016. THEY BROUGHT THE PATIENT BACK TO THE OR TO TREAT AN INFECTION THEY HAD DETERMINED WAS SOMEWHERE INTERNAL NEAR THE L4-5 INTERBODY AREA. UPON EXPLORATION, THEY FOUND AN INFECTED AREA TRANS-PSOAS IN THAT AREA THAT ALSO EXTENDED INTO THE INTERBODY AREA WHERE THE CAGE WAS PLACED. THEY REMOVED THE SCREWS AND THE CAGE AND DISCOVERED THAT THE INFECTION HAD FOUND IT'S WAY INTO THE DISC SPACE, DISSOLVED THE BONE GRAFT MATERIAL AND LOOSENED THE INTERFACE BETWEEN THE CAGE AND THE ENDPLATES. ONE OF THE ENDPLATES APPEARED TO BE FRACTURED, SO THE SURGEON DECIDED NOT TO REPLACE THE CAGE, AND INSTEAD TO THOROUGHLY CLEAN AND WASH THE AREA, PACK THE DISC SPACE WITH CANCELLOUS CHIPS AND OTHER BONE GRAFT MATERIAL AND COME BACK LATER WITH POSTERIOR PEDICLE SCREWS TO STABILIZE THE JOINT. THE DO NOT THINK THE INFECTION IS DEVICE RELATED, BUT IT IS NOT KNOWN WHAT CAUSED THE INFECTION OR WHERE IT ORIGINATED.

  Patient problems: Unspecified Infection

  MAUDE report 6304104 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2-LEVEL ALIF AT L4-5 AND L5-S1 WAS PERFORMED ON THE PATIENT ON (B)(6) 2016. THEY BROUGHT THE PATIENT BACK TO THE OR TO TREAT AN INFECTION THEY HAD DETERMINED WAS SOMEWHERE INTERNAL NEAR THE L4-5 INTERBODY AREA. UPON EXPLORATION, THEY FOUND AN INFECTED AREA TRANS-PSOAS IN THAT AREA THAT ALSO EXTENDED INTO THE INTERBODY AREA WHERE THE CAGE WAS PLACED. THEY REMOVED THE SCREWS AND THE CAGE AND DISCOVERED THAT THE INFECTION HAD FOUND IT'S WAY INTO THE DISC SPACE, DISSOLVED THE BONE GRAFT MATERIAL AND LOOSENED THE INTERFACE BETWEEN THE CAGE AND THE ENDPLATES. ONE OF THE ENDPLATES APPEARED TO BE FRACTURED, SO THE SURGEON DECIDED NOT TO REPLACE THE CAGE, AND INSTEAD TO THOROUGHLY CLEAN AND WASH THE AREA, PACK THE DISC SPACE WITH CANCELLOUS CHIPS AND OTHER BONE GRAFT MATERIAL AND COME BACK LATER WITH POSTERIOR PEDICLE SCREWS TO STABILIZE THE JOINT. THE DO NOT THINK THE INFECTION IS DEVICE RELATED, BUT IT IS NOT KNOWN WHAT CAUSED THE INFECTION OR WHERE IT ORIGINATED.

  Patient problems: Unspecified Infection

  MAUDE report 6304088 ↗