OsteoMed 450-0021-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845694012157), received between Aug 12, 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 18, 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 12820679 ↗
• 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 12389466 ↗
• MalfunctionAug 12, 2021Unintended Electrical Shock; Unintended Electrical Shock

  ON (B)(6) 2021, THE CUSTOMER CONTACTED THEIR OSTEOMED REPRESENTATIVE, REPORTING THAT THE CUSTOMER HAD EXPERIENCED A SIMILAR SENSATION WITH THE LOANER CONSOLE AND MOTOR THAT WAS SENT TO THEM IN EXCHANGE FOR THE UNITS LISTED ON THE FER (B)(6) 2021. 6/21/2021 - EMAIL RECEIVED FROM PRODUCT MANAGER, WHO CONTACTED THE OFFICE AGAIN AND REPORTS THAT THE SURGEON ASSISTANT FIGURED OUT THAT THE ISSUE WAS WITH THE UNIT PLUGGED INTO A SURGE PROTECTOR. AFTER PLUGGING DIRECTLY INTO THE WALL SOCKET THE ISSUE WAS SOLVED. THE SURGEON DOES NOT BELIEVE THE PRODUCT WAS THE ISSUE. 8/6/2021 - COMPLAINT DETERMINED TO BE REPORTABLE.

  Patient problems: Electric Shock

  MAUDE report 12316298 ↗