Modulus 1225050P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517726841), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE WHERE A SPACER CAGE WAS PLACED. THE PATIENT WAS EXPERIENCING POST OPERATIVE PAIN, AND AROUND THE SIX MONTH FOLLOW UP APPOINTMENT HER SURGEON DISCOVERED THE CAGE WAS LIGHTLY ROTATING OBLIQUELY AND MIGRATING ANTERIOR. A REVISION OCCURRED ON (B)(6) 2020 WHERE THE SURGEON MADE MULTIPLE ATTEMPTS TO REMOVE THE CAGE, BUT WAS UNABLE TO ENGAGE THE RE ENGAGE THE CAGE. IT WAS NOTED THAT SOME BONE UNION MAY HAVE ALREADY BEEN OCCURRING COMPLICATING REMOVAL. IN DISCUSSION WITH THE SURGEON IT IS UNKNOWN AS TO WHETHER HE WILL BE ABLE TO RETRIEVE IT IN THE FUTURE.

  Patient problems: Pain

  MAUDE report 10797016 ↗