Investigating complications of extreme lateral interbody fusion (XLIF) in the food and drug administration manufacturer and user facility device experience database.

BACKGROUND

The extreme lateral interbody fusion (XLIF) approach is being increasingly adopted to alleviate complications that are commonplace with other approaches; however, an analysis of the device malfunctions and patient injuries associated with the procedure was not available. The purpose of this study was to search the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE) for medical device reports (MDRs) associated with the XLIF procedure and categorically analyze the device and patient complications.

METHODS

MDRs from Jan. 2012 to Nov. 2022 from the MAUDE database regarding the XLIF procedure were filtered and analyzed by two independent reviewers. The complications associated with each MDR were then categorized into device malfunctions and patient injuries, further reclassified into intra-operative and post-operative complications, and analyzed for their relative frequencies.

RESULTS

The most common intra-operative device malfunction was the fracture of an instrument other than the interbody/cage at 8.1% (25/308) and the least common intra-operative device malfunction was an inability to insert the interbody/cage at 3.6% (11/308). The most common post-operative device malfunction was migration of something other than the cage at 5.2% (16/208) and the least common was cage migration at 2.3% (7/208). Post-operative wound issues were the most common patient injury at 7.3% (23/314) and the least common injuries included intra-operative paralysis and intra-operative death at 0.6% (2/314).

CONCLUSION

Although the XLIF procedure was developed to mitigate vascular injury, the predominant complication continues to be vascular injury, followed by organ injury based on MDRs submitted to the MAUDE database. This study provides an extensive search into the device malfunctions and patient injuries specific to the XLIF procedure, which has not been studied before. Such analysis provides a valuable focus for manufacturers and surgeons to improve patient safety by refining device design and optimizing surgical techniques.