Modulus 1225255P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517726940), received between Nov 26, 2024 and Feb 19, 2025 — classified as 2 injuries.

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.

• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LIB COMPLICATIONS STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AT L3/4 AND L4/5 WITH POSTERIOR FIXATION FROM L3 TO L5. ON (B)(6) 2024 THE PATIENT REPORTED THAT HE BENT OVER AND FELT PAIN IN HIS LOWER BACK, DEVELOPED SOME CRAMPING IN HIS RIGHT HAMSTRING, INTERMITTENT PAIN AND ACHING INTO HIS BILATERAL HIPS, NUMBNESS INTO THE MIDDLE TOES OF HIS BILATERAL FEET. HE OCCASIONALLY EXPERIENCES SOME TINGLING INTO THE BILATERAL THIGHS, RIGHT GREATER THAN LEFT THAT TYPICALLY OCCURS WITH OVERUSE OR PROLONGED SITTING. IMAGING IDENTIFIED NONDISPLACED BILATERAL PARS DEFECTS AT L5 AND POSSIBLE PEDICLE FRACTURE. THE PATIENT IS BEING TREATED WITH MEDICATION (GABAPENTIN AND TIZANIDINE) AS NEEDED AS WELL AS A HOME EXERCISE PROGRAM WITH PIRIFORMIS STRETCHING. NO REVISION HAS BEEN COMPLETED AT THIS TIME.

  Patient problems: Bone Fracture(s); Cramp(s) /Muscle Spasm(s); Numbness; Pain

  MAUDE report 21411902 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LIB STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L3/4 AND L4/5 WITH POSTERIOR FIXATION FROM L3 TO L4. ON (B)(6) 2024 WHILE HOSPITALIZED POST-OPERATIVELY, PATIENT NOTED INCREASED FATIGUE, PROGRESSIVE SHORTNESS OF BREATH DECREASED ABILITY TO PULL AS HIGH ON HIS INCENTIVE SPIROMETER. HYPOTENSION WAS ALSO NOTED. A COMPUTED TOMOGRAPHY PULMONARY EMBOLUS STUDY REVEALED A NEW SEGMENTAL RIGHT LOWER LOBE PULMONARY EMBOLISM. HEPARIN WAS ADMINISTERED VIA IV AND A NASAL CANNULA PROVIDED FROM (B)(6) 2024. PATIENT DISCHARGED ON (B)(6) 2024 WITH THERAPEUTIC ANTICOAGULATION PRESCRIPTION FOR 3-6 MONTHS. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Pulmonary Embolism; Pulmonary Hypertension

  MAUDE report 20781343 ↗