Modulus 67940037P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517959430), received between Oct 18, 2022 and May 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• MalfunctionMay 12, 2026Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT WHO UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY. THE CAGE WAS PLACED BETWEEN C4/5 VERTEBRAE IN THE PRIMARY SURGERY, THE FITTING WAS GOOD AND THE WOUND WAS CLOSED. HOWEVER, THE NEXT DAY THE CAGE HAD MOVED FORWARD, AND A CT SCAN TAKEN THE FOLLOWING WEEK SHOWED THAT IT HAD MOVED EVEN FURTHER FORWARD. SO, THE SURGEON REMOVED THE CAGE AND INSERTED NEW ONE WITH PLATE FOR FIXATION. WE DID NOT OBTAIN THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151292 ↗
• InjuryOct 18, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C4/5 WITHOUT ISSUE. ON (B)(6) 2022 THE PATIENT STARTED TO EXPERIENCE NUMBNESS IN FEET. ON (B)(6) 2022 THE PATIENT EXPERIENCED DEBILITATING PAIN, NUMBNESS AND TINGLING IN HIS EXTREMITIES AND WAS ADMITTED AND TREATED FOR IDENTIFIED BILATERAL PULMONARY EMBOLISMS AND HORNER'S SYNDROME. ON (B)(6) 2022 THE PATIENT STARTED EXPERIENCING EXTREME FATIGUE, LACK OF HUNGER AND NAUSEA. ON (B)(6) 2022 THE PATIENT SPOKE TO SURGEON ABOUT HIS PREEXISTING ALLERGY TO NICKLE AND COBALT AND WAS TREATED WITH STEROIDS AND THE SYMPTOMS SLIGHTLY IMPROVED AND ADDITIONAL ALLERGY EVALUATION IS UNDERWAY AND REQUESTING PRODUCT MATERIAL LISTING FOR CONTINUED EVALUATION.

  Patient problems: Fatigue; Hypersensitivity/Allergic reaction; Nausea; Numbness; Pain; Pulmonary Embolism

  MAUDE report 15621308 ↗