DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169502406), received between May 9, 2017 and Nov 16, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT POST-OP, SCREWS MIGRATED ANTERIORLY. NO FUTURE SURGERY WAS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037760 ↗
• MalfunctionMay 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREW MIGRATED. PATIENT HAD POOR BONE QUALITY. PATIENT COMPLICATIONS WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6580885 ↗
• MalfunctionMay 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREW MIGRATED. PATIENT HAD POOR BONE QUALITY. PATIENT COMPLICATIONS WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6580881 ↗
• MalfunctionMay 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT AFTER THREE MONTHS OF THE OPERATION, SURGEON OBSERVED THAT THE PLATE HAD PULLED AWAY FROM THE SACRAL BODY. SCREWS WERE PULLED OUT OF THE BONE AND ARE STILL RETAINED IN THE PLATE. HOWEVER, THE PATIENT IS CLINICALLY DOING VERY WELL AND SO AT THIS TIME NO FURTHER ACTION WILL BE TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553375 ↗
• MalfunctionMay 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT AFTER THREE MONTHS OF THE OPERATION, SURGEON OBSERVED THAT THE PLATE HAD PULLED AWAY FROM THE SACRAL BODY. SCREWS WERE PULLED OUT OF THE BONE AND ARE STILL RETAINED IN THE PLATE. HOWEVER, THE PATIENT IS CLINICALLY DOING VERY WELL AND SO AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553374 ↗
• MalfunctionMay 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT AFTER THREE MONTHS OF THE OPERATION, SURGEON OBSERVED THAT THE PLATE HAD PULLED AWAY FROM THE SACRAL BODY. SCREWS WERE PULLED OUT OF THE BONE AND ARE STILL RETAINED IN THE PLATE. HOWEVER, THE PATIENT IS CLINICALLY DOING VERY WELL AND SO AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553373 ↗
• MalfunctionMay 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT AFTER THREE MONTHS OF THE OPERATION, SURGEON OBSERVED THAT THE PLATE HAD PULLED AWAY FROM THE SACRAL BODY. SCREWS WERE PULLED OUT OF THE BONE AND ARE STILL RETAINED IN THE PLATE. HOWEVER, THE PATIENT IS CLINICALLY DOING VERY WELL AND SO AT THIS TIME NO FURTHER ACTION WILL BE TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553370 ↗