Alpha 2 MPO ePlus S0821-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169862234), received between Feb 21, 2019 and Feb 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2019Material Integrity Problem; Material Integrity Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE INTERNAL DEVICE WAS NO LONGER ADHERING TO THE EXTERNAL DEVICES EVEN WITH A 12 EXTERNAL PLATE. THE PATIENT HAD LOST A DEVICE AND EVEN WITH A SOFTBAND, THE PATIENT WAS NO LONGER GETTING BENEFIT. THE DEVICE WAS SCHEDULED TO BE REMOVED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD NOT BEEN EXPOSED TO ANY STRONG MAGNETIC FIELDS AND DENIED ANY HEAD TRAUMA AS WELL. THE HEALTH CARE PROVIDER PERFORMED NUMEROUS SKIN FLAP REVISIONS AND HAD CONCERNS AS THE PATIENT REPORTED POST-OPERATIVE ISSUES/PAIN EVEN YEARS AFTER THE PROCEDURE. THE HCP NOTED THAT ALL OPTIONS HAD BEEN WEIGHED CAREFULLY AND THE FAMILY AND THE TEAM FELT THE BEST OPTION FOR THE PATIENT WAS TO REMOVE THE IMPLANT AND USE A DIFFERENT DEVICE. ON FOLLOW-UP, IT WAS REPORTED THAT THE IMPLANT HAS BEEN REMOVED ON (B)(6) 2019.

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 8359475 ↗