OsteoMed 213-0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694002998), received between Aug 24, 2022 and Aug 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Signal Artifact/Noise” (2 reports).

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.

• InjuryAug 24, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2022 TO REMOVE A BRAIN TUMOR AND THE OSTEOMED DEVICES WERE USED TO CLOSE THE CRANIOTOMY. IT WAS LATER REPORTED BY THE SURGEON (EVENT DATE UNKNOWN) THAT THE SURGEON IS UNABLE TO PLAN THE SEQUENTIAL RADIOTHERAPY TREATMENT FOR THE PATIENT'S CANCER DUE TO THE ARTIFACTS GENERATED BY THE TITANIUM PLATES AND SCREWS ON "THE MDR EXAM". IT IS CURRENTLY UNKNOWN WHAT KIND OF IMAGING WAS PERFORMED. IT WAS REPORTED THE DEVICES "WERE NOT REMOVED FROM THE PATIENT YET". NO ADVERSE PATIENT CONSEQIENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBERS 2027754-2022-00039, 2027754-2022-00040, 2027754-2022-00042, 2027754-2022-00043, 2027754-2022-00044, AND 2027754-2022-00045 FOR THE OTHER IMPLANTED DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283294 ↗
• InjuryAug 24, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2022 TO REMOVE A BRAIN TUMOR AND THE OSTEOMED DEVICES WERE USED TO CLOSE THE CRANIOTOMY. IT WAS LATER REPORTED BY THE SURGEON (EVENT DATE UNKNOWN) THAT THE SURGEON IS UNABLE TO PLAN THE SEQUENTIAL RADIOTHERAPY TREATMENT FOR THE PATIENT'S CANCER DUE TO THE ARTIFACTS GENERATED BY THE TITANIUM PLATES AND SCREWS ON "THE MDR EXAM". IT IS CURRENTLY UNKNOWN WHAT KIND OF IMAGING WAS PERFORMED. IT WAS REPORTED THE DEVICES "WERE NOT REMOVED FROM THE PATIENT YET". NO ADVERSE PATIENT CONSEQIENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBERS 2027754-2022-00039, 2027754-2022-00041, 2027754-2022-00042, 2027754-2022-00043, 2027754-2022-00044, AND 2027754-2022-00045 FOR THE OTHER IMPLANTED DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283248 ↗