OsteoMed 450-0084Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845694012263), received between Aug 11, 2021 and Nov 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electromagnetic Compatibility 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. 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.

• MalfunctionNov 16, 2021Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  ON OCTOBER 26, 2021, THE CUSTOMER CONTACTED OSTEOMED PRODUCT MANAGER BY EMAIL. PER THE EMAIL: "THE CONSOLE UNIT WILL SPONTANEOUSLY BEGIN RUNNING ON REVERSE, WITHOUT ANYONE PRESSING THE FOOT PEDAL! " THE INVOLVED PART NUMBERS ARE AS FOLLOWS: COMPLAINT #, PART #, DESCRIPTION, SERIAL #; (B)(4), 450-0084, SERIES II LOW PROFILE MODULAR MOTOR UNIT, (B)(4); (B)(4), 450-0021, POWER CONTROL CONSOLE 2 (B)(4); (B)(4), 450-0390, BMF FOOTSWITCH (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820520 ↗
• MalfunctionAug 30, 2021Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  ON (B)(6) 2021, THE CUSTOMER CONTACTED OSTEOMED PRODUCT MANAGER, REPORTING THAT THE OSTEOMED 450-0021, POWER CONTROL CONSOLE 2 WITH SERIAL NUMBER (B)(4) WAS INTERFERING WITH GE INTERCARE AND CRITICARE MONITORS. THE INVOLVED PART NUMBERS ARE AS FOLLOWS: COMPLAINT # PART # DESCRIPTION SERIAL # (B)(4), 450-0021, POWER CONTROL CONSOLE 2, (B)(4). (B)(4). 450-0390, BMF FOOTSWITCH, (B)(4). (B)(4), 450-0084, SERIES II LOW PROFILE MODULAR MOTOR UNIT, (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389476 ↗
• MalfunctionAug 11, 2021Unintended Electrical Shock; Unintended Electrical Shock

  ON MAY 10, 2021 OSTEOMED WAS NOTIFIED THAT, UNIT 420-0021-00 AND SN (B)(4) WAS SHOCKING THE PATIENTS. PER THE CUSTOMER:"WE HAVE THIS UNIT THAT IS SHOCKING THE PATIENTS. WE SEEM TO THINK IT IS THE CORD BECAUSE IT HAS A KINK IN IT. " ON 6/8/2021 OSTEOMED REACHED OUT TO THE REPORTING CUSTOMER AND COLLECTED: I SPOKE WITH THE OFFICE MANAGER THIS MORNING, WHO ALSO REPORTED THE COMPLAINT. SHE CONFIRMED THAT THERE WAS NO PATIENT HARM DUE TO THE "SHOCKING SENSATION" THAT WAS REPORTED. (HARM= BURNS, CUTS, RED MARKS OR ANY INJURY THAT WOULD REQUIRE TREATMENT). THE SURGEON REPORTED THAT EVERY TIME THE DRILL TOUCHED THE PATIENT THERE WAS A SENSATION THAT WAS NOT REPORTED AS PAINFUL. TO RESOLVE, THE SURGEON TURNED OFF THE MACHINE AND USED ANOTHER ONE. THERE WERE NO DELAYS IN SURGERY TO REPORT. (B)(6) COULD ALSO NOT THINK OF ANY DAMAGE TO THE POWER CONSOLE TO REPORT. MDR DETERMINATION FORM COMPLETED. BASED ON INFORMATION RECEIVED, THERE IS NO INFORMATION THAT REPORTS ANY HARM TO A PATIENT OR CONFIRMED MALFUNCTION OF THE PRODUCT. COMPLAINT DETERMINED NOT TO BE MDR REPORTABLE. ON 6/14/2021 AS A FOLLOW UP: THE CUSTOMER CONTACTED THE SALES REPRESENTATIVE WHO REPORTED THAT THE CUSTOMER HAD EXPERIENCED

  Patient problems: Electric Shock

  MAUDE report 12310902 ↗