Modulus 1221050P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517726605), received between Mar 30, 2022 and Feb 19, 2025 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 19, 2025Migration; Migration

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LIB COMPLICATIONS STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TWO LEVEL EXTREME LATERAL INTERBODY FUSION AT L3/4 AND L4/5 WITH POSTERIOR FIXATION FROM L3 TO L5. ON (B)(6) 2022 FOLLOW UP RADIOGRAPHS SHOWED L4 AND L5 COMPRESSION FRACTURES WITH CRANIAL MIGRATION OF ANTERIOR BODY FRAGMENTS AND INTRADISCAL SPACERS, INSTABILITY AND LOSS OF CORRECTION. NO REVISION PLANNED AT THIS TIME PATIENT TREATED WITH MEDICATION, BRACING AND CLOSE MONITORING.

  Patient problems: Bone Fracture(s)

  MAUDE report 21412346 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA ADVANCED MATERIALS STUDY IN EXTREME LATERAL INTERBODY FUSION CLINICAL REVIEW THAT A PATIENT UNDERWENT AN EXTREME LUMBAR INTERBODY FUSION AT L4/5 ON (B)(6) 2021. ON (B)(6) 2022 DURING A FOLLOW UP AN ACUTE FRACTURE WAS VISUALIZED THROUGH THE L5 BODY USING AN MRI LUMBAR SPINE WITHOUT CONTRAST DONE. TREATMENT INCLUDED PHYSICAL THERAPY.

  Patient problems: Vertebral Fracture

  MAUDE report 13956045 ↗