Modulus 1221245P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517726667), received between Oct 10, 2024 and Oct 18, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Migration; Migration

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE AMS IN XLIF STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L3/4. ON (B)(6) 2024 THE PATIENT WAS IDENTIFIED WITH L4 SUBSIDENCE, NO REVISION IS PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488005 ↗
• MalfunctionOct 10, 2024Migration; Migration

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE AMS IN (B)(4) STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023 A PATIENT IDENTIFIED WITH ADJACENT SEGMENT DISEASE FROM A PREVIOUS L5-S1 INTERBODY FUSION WITH AN UNKNOWN PRODUCT UNDERWENT A TWO LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L3/4 AND L4/5 WITH POSTERIOR FIXATION L3 TO S1 WITH ANOTHER MANUFACTURES SCREWS. ON (B)(6) 2024 THE PATIENT WAS IDENTIFIED WITH UTI- SEPSIS AND UNDERWENT A REVISION PROCEDURE WHERE THE NOTED "INFECTED INSTRUMENTATION WAS REMOVED FROM L3-S1, EXPLORATION OF FUSION L3-S1 WITH IRRIGATION AND DEBRIDEMENT OF THE POSTERIOR LUMBAR WOUND AND EXCISIONAL DEBRIDEMENT OF THE IDENTIFIED L2-3 DISCITIS AND OSTEOMYELITIS. ON (B)(6) 2024 THE PATIENT WAS REPORTEDLY IDENTIFIED WITH L3-L5 SUBSIDENCE AND NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424147 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTED ERRORS LISTED ON H10.

  Patient problems: Osteomyelitis; Sepsis

  MAUDE report 20422829 ↗