OsteoMed 210-0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845694001250), received between Dec 4, 2023 and Jan 8, 2024 — classified as 6 injuries.

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.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466326 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466302 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466265 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466264 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 10 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263517 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 9 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263515 ↗