Modulus 1181055P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517725905), received between Oct 6, 2023 and Dec 21, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Migration; Migration

  ON (B)(6) 2023 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L2 TO L5. THE SURGERY WAS COMPLETED WITH NO ISSUE BUT IT WAS OBSERVED THAT THE IMPLANTED VERTEBRAL SPACER WAS MISALIGNED AT THE L3/L4 LEVEL AND POSTERIOR FIXATION WAS IMPLANTED AS IS. ON A UNKNOWN DATE IN NOVEMBER OF 2023 IT WAS REPORTED THE PATIENT WAS EXPERIENCING BACK AND LOWER LIMB PAIN. THE PATIENT VISITED THE PHYSICIAN WHERE IMAGES DISCOVERED FURTHER MIGRATION OF THE L3/4 CAGE. THE IMAGES ALSO REVEALED FUSION HAD BEEN ACHIEVED AT L2/3, L4/5, BUT NOT AT L3/4. A REVISION SURGERY WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2023 BUT DESPITE REQUESTING NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THE REVISION. THE PATIENT POST OP ACTIVITY LEVELS OR WHETHER THEY EXPERIENCED ANY ACCIDENTS OR FALLS IS UNKNOWN BUT THEY WERE REPORTED TO HAVE FUSED ON ALL LEVEL EXCEPT THE MIGRATED LEVEL OF THE CONSTRUCT.

  Patient problems: Pain

  MAUDE report 18377564 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL INTERBODY FUSION PROCEDURE AT L3/4 ON AN UNKNOWN DATE IN 2023. SUBSEQUENTLY, A BACTERIAL INFECTION WAS DIAGNOSED UPON ADMISSION TO THE HOSPITAL FOR UNKNOWN REASONS ON AN UNKNOWN DATE. THE PATIENT REPORTED HAVING EXPERIENCED SEVERE PAIN AND SPASMS IN THE TIME FOLLOWING THE INITIAL SURGERY. AN MRI WAS CONDUCTED ON AN UNKNOWN DATE AND THE REPORTED FINDINGS WERE EDEMA IN THE DISC SPACE, ADJACENT VERTEBRAL BODIES, VENTRAL EPIDURAL SPACE, AND PSOAS MUSCLE WITH APPARENT LEFT PSOAS ABSCESS. THE FINDINGS WERE NOTED TO BE CONCERNING FOR DISCITIS OSTEOMYELITIS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH BROAD SPECTRUM IV ANTIBIOTICS. SUBSEQUENTLY, THE PATIENT WAS RELEASED WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) TO CONTINUE IV ANTIBIOTICS FOR 6-8 WEEKS. IT WAS NOTED THAT, DUE TO A LAB ERROR AT THE HOSPITAL, THE BACTERIA WAS NOT SPECIATED AND THERE WAS NO ORIGINAL SPECIMEN LEFT TO DO SO. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Cramp(s) /Muscle Spasm(s); Osteomyelitis; Pain; Swelling/ Edema

  MAUDE report 17891717 ↗