OsteoMed 209-2008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845694001045), received between Dec 27, 2022 and Dec 27, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2022 DUE TO ISSUES WITH THE DEVICES INITIALLY IMPLANTED ON 20 (B)(6) 2022 (PREVIOUSLY REPORTED IN REPORT NUMBER 2027754-2022-00142 AND ASSOCIATED REPORTS). AFTER THE (B)(6) 2022 REVISION PROCEDURE, IT WAS REPORTED THAT ON 01 DECEMBER 2022, THE PATIENT REPORTED FEELING "LOOSE SCREW ON THE LEFT SIDE". IT WAS REPORTED A NEW EXPLORATION PROCEDURE WAS CARRIED OUT, AND "A NEW LOSS OF THE PLATE AND BICORTICAL SCREWS WAS FOUND". BONE MATERIAL WAS COLLECTED, AND THE RESULTS ARE PENDING. THE PATIENT HAS NOT REPORTED SYMPTOMS AND IMAGING WAS PERFORMED ON (B)(6) 2022 SUGGESTING A RADIOLUCENT HALO IN THE RIGHT SIDE SCREWS. THE PATIENT IS CURRENTLY IN WEEKLY FOLLOW-UP AND IMAGING. THERE IS SUSPECTED METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 7 OF 12 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049533 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2022 DUE TO ISSUES WITH THE DEVICES INITIALLY IMPLANTED ON (B)(6) 2022 (PREVIOUSLY REPORTED IN REPORT NUMBER 2027754-2022-00142 AND ASSOCIATED REPORTS). AFTER THE 21 OCTOBER 2022 REVISION PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT REPORTED FEELING "LOOSE SCREW ON THE LEFT SIDE". IT WAS REPORTED A NEW EXPLORATION PROCEDURE WAS CARRIED OUT, AND "A NEW LOSS OF THE PLATE AND BICORTICAL SCREWS WAS FOUND". BONE MATERIAL WAS COLLECTED, AND THE RESULTS ARE PENDING. THE PATIENT HAS NOT REPORTED SYMPTOMS AND IMAGING WAS PERFORMED ON (B)(6) 2022 SUGGESTING A RADIOLUCENT HALO IN THE RIGHT SIDE SCREWS. THE PATIENT IS CURRENTLY IN WEEKLY FOLLOW-UP AND IMAGING. THERE IS SUSPECTED METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 5 OF 12 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049514 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2022 DUE TO ISSUES WITH THE DEVICES INITIALLY IMPLANTED ON (B)(6) 2022 (PREVIOUSLY REPORTED IN REPORT NUMBER 2027754-2022-00142 AND ASSOCIATED REPORTS). AFTER THE (B)(6) 2022 REVISION PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT REPORTED FEELING "LOOSE SCREW ON THE LEFT SIDE". IT WAS REPORTED A NEW EXPLORATION PROCEDURE WAS CARRIED OUT, AND "A NEW LOSS OF THE PLATE AND BICORTICAL SCREWS WAS FOUND". BONE MATERIAL WAS COLLECTED, AND THE RESULTS ARE PENDING. THE PATIENT HAS NOT REPORTED SYMPTOMS AND IMAGING WAS PERFORMED ON (B)(6) 2022 SUGGESTING A RADIOLUCENT HALO IN THE RIGHT SIDE SCREWS. THE PATIENT IS CURRENTLY IN WEEKLY FOLLOW-UP AND IMAGING. THERE IS SUSPECTED METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 6 OF 12 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049511 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2022 DUE TO ISSUES WITH THE DEVICES INITIALLY IMPLANTED ON (B)(6) 2022 (PREVIOUSLY REPORTED IN REPORT NUMBER 2027754-2022-00142 AND ASSOCIATED REPORTS). AFTER THE (B)(6) 2022 REVISION PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT REPORTED FEELING "LOOSE SCREW ON THE LEFT SIDE". IT WAS REPORTED A NEW EXPLORATION PROCEDURE WAS CARRIED OUT, AND "A NEW LOSS OF THE PLATE AND BICORTICAL SCREWS WAS FOUND". BONE MATERIAL WAS COLLECTED, AND THE RESULTS ARE PENDING. THE PATIENT HAS NOT REPORTED SYMPTOMS AND IMAGING WAS PERFORMED ON (B)(6) 2022 SUGGESTING A RADIOLUCENT HALO IN THE RIGHT SIDE SCREWS. THE PATIENT IS CURRENTLY IN WEEKLY FOLLOW-UP AND IMAGING. THERE IS SUSPECTED METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 4 OF 12 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049481 ↗