Modulus 1181855P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517726063), received between Mar 3, 2023 and Apr 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2022(?) THE PATIENT UNDERWENT SPINAL CAGE INSERTION USING THE XLIF METHOD BETWEEN THE THIRD AND FIFTH LUMBAR VERTEBRAE, FOLLOWED BY VERTEBRAL FUSION SURGERY BETWEEN THE THIRD AND FIFTH LUMBAR VERTEBRAE. THEN ON (B)(6) 2026 OUR SALES REPRESENTATIVE VISITED THE MEDICAL INSTITUTION FOR A POSTOPERATIVE FOLLOW-UP AND RECEIVED A REPORT THAT THE PATIENT HAD DEVELOPED NEUROLOGICAL SYMPTOMS. THE SURGEON SUGGESTED THAT THE SHIM MAY HAVE SHIFTED POSTERIORLY DURING TRACTION DEVICE PLACEMENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24866326 ↗
• MalfunctionApr 1, 2025Material Deformation; Material Deformation

  ON (B)(6) 2024 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L4/5 USING AN INTERBODY SPACER AND POSTERIOR FIXATION FROM ANOTHER MANUFACTURER. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2025 IT WAS DISCOVERED THAT THE INTERBODY APPEARED TO BE DAMAGED AND THAT THE LOCK SCREW ON THE NON-NUVASIVE DEVICE'S RIGHT L4 PEDICLE SCREW HAD BACKED OUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED AND NO REVISION IS PLANNED AS THE PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739868 ↗
• MalfunctionMar 3, 2023Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE FROM L2 TO L4. THE SURGERY WAS COMPLETED WITH OUT ISSUE OR COMPLICATION TO THE PATIENT. THE PATIENT HAD A SUBSEQUENT FOLLOW UP AND NO ISSUE WAS FOUND WITH THE PATIENT OR CONSTRUCT. ON (B)(6) 2023 THE PATIENT HAD ANOTHER FOLLOW UP APPOINTMENT WHERE IT WAS DISCOVERED THE IMPLANTED CAGE AT THE L3/L4 LEVEL HAD FRACTURED IN HALF. THE PATIENT CLAIMS TO HAVE EXPERIENCED NO FALLS OR OTHER ACCIDENTS AND IS CURRENTLY EXPERIENCING NO ADVERSE PAIN OR CONSEQUENCES AS A RESULT OF THE FRACTURED IMPLANT. THE CAGE CURRENTLY REMAINS IN SITU WITH NO CURRENT PLANS FOR REVISION. THE PATIENT IS UNDER OBSERVATION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482464 ↗