Disposable Reflective Marker Sphere (DRMS) 41773Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20805832010012), received between May 29, 2015 and May 29, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionMay 29, 2015Material Separation; Defective Device; Material Integrity Problem

  THIS EVENT WAS COMMUNICATED BY A CUSTOMER WHO RECEIVED A COMPLAINT FROM (B)(6). THE DESCRIPTION AS PROVIDED BY THE INITIAL COMPLAINANT TO OUR CUSTOMER IS AS FOLLOWS: "THE DEFECTIVE SPHERES SEEM TO HAVE HALF OF THE REFLECTIVE COATING LAYER SOMEWHAT UNWRAPPED FROM THE SPHERE UPON OPENING. THAT IS, THERE IS AN OPEN SEAM BETWEEN THE TWO HEMISPHERES OF REFLECTIVE WRAPPING" FURTHER FOLLOW-UP WITH THE INITIAL COMPLAINANT INDICATES THAT WHEN THE SPHERES WERE SCREWED ON TO THE ARRAY, THEY SPLIT DOWN THE MIDDLE, EVEN WITHOUT MUCH FORCE AND THE TWO HEMISPHERES SEPARATED. INITIAL COMPLAINANT STATED THIS HAPPENED PRIOR TO AND DURING SURGERY. INITIAL COMPLAINANT CONFIRMED NO PATIENT INJURY OR OTHER SERIOUS HARM OCCURRED AND NO SERIOUS DETERIORATION TO PATIENT HEALTH. PROCEDURE WAS COMPLETED WITH A NEW PACKAGE OF SPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 4805714 ↗