OsteoMed 450-0034Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845694015646), received between Feb 10, 2023 and Apr 30, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Power Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Power Problem; Power Problem

  A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON 12 APRIL 2024, THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED "UNIT IS IS CONTINUOUSLY RUNNING DUE TO A MALFUNCTIONING FLEX CIRCUIT IN THE CABLE ASSEMBLY ". AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER WAS CONTACTED TO DETERMINE IF ANY SURGERY OR PATIENT WAS IMPACTED. THE CUSTOMER RESPONDED THAT THIS ISSUE WAS NOTED IN THEIR WAREHOUSE PRIOR TO ANY SURGERY WITH NO PATIENT, USER, OR SURGERY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212762 ↗
• MalfunctionApr 30, 2024Power Problem; Power Problem

  A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON (B)(6) 2024, THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED "UNIT IS IS CONTINUOUSLY RUNNING DUE TO A MALFUNCTIONING FLEX CIRCUIT IN THE CABLE ASSEMBLY ". AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER WAS CONTACTED TO DETERMINE IF ANY SURGERY OR PATIENT WAS IMPACTED. THE CUSTOMER RESPONDED THAT THIS ISSUE WAS NOTED IN THEIR WAREHOUSE PRIOR TO ANY SURGERY WITH NO PATIENT, USER, OR SURGERY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212678 ↗
• MalfunctionJan 4, 2024Power Problem; Power Problem

  A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON 12 DECEMBER 2023, THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED "UNIT IS DIFFICULT TO INSERT AND REMOVE FROM THE CONSOLE DUE TO DAMAGED CABLE CONNECTOR. MOTOR UNIT IS CONTINUOUSLY RUNNING DUE TO A MALFUNCTION FLEX CIRCUIT IN THE CABLE ASSEMBLY ". AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER WAS CONTACTED TO DETERMINE IF ANY SURGERY OR PATIENT WAS IMPACTED. THE CUSTOMER RESPONDED THAT THIS ISSUE WAS NOTED IN THEIR WAREHOUSE PRIOR TO ANY SURGERY WITH NO PATIENT, USER, OR SURGERY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18448136 ↗
• MalfunctionOct 2, 2023Power Problem; Power Problem

  SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON (B)(6) 2023. THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED THE DEVICE WAS RUNNING CONTINUOUSLY DUE TO A MALFUNCTIONING CABLE ASSEMBLY, AND MOTOR UNIT ALSO HAS WORN AND DIRTY ROTOR ASSEMBLY". AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER WAS CONTACTED TO DETERMINE IF ANY SURGERY OR PATIENT WAS IMPACTED. THE CUSTOMER RESPONDED THAT THIS ISSUE WAS NOTED IN THEIR WAREHOUSE POST SURGERY WITH NO PATIENT, USER, OR SURGERY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857713 ↗
• MalfunctionApr 12, 2023Power Problem; Power Problem

  A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON (B)(6) 2023, THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED THE DEVICE WAS RUNNING CONTINUOUSLY DUE TO A MALFUNCTIONING CABLE ASSEMBLY. AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER IS BEING CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THESE FINDINGS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728879 ↗
• MalfunctionFeb 10, 2023Power Problem; Power Problem

  A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON 09 JANUARY 2023, THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED THE DEVICE WAS RUNNING CONTINUOUSLY DUE TO A MALFUNCTIONING FLEX CIRCUIT IN THE CABLE ASSEMBLY. AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER IS BEING CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THESE FINDINGS.

  Patient problems: Insufficient Information

  MAUDE report 16359149 ↗