OsteoMed 211-2006Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00845694002448), received between Sep 25, 2023 and Jan 8, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 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 18466411 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)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 18466304 ↗
• 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 18466303 ↗
• 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 05 OCTOBER 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 18466300 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 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 18466278 ↗
• 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 18466267 ↗
• MalfunctionSep 25, 2023Break; Break

  AN "ADVERSE EVENT REPORT" WAS RECEIVED FROM THE HEALTH AUTHORITY IN CHINA. PER THE ADVERSE EVENT REPORT, "THE PATIENT WAS DIAGNOSED WITH AN "ANEURYSM" AND UNDERWENT ANEURYSM CLIPPING SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2019. WHEN USING THE CRANIOFACIAL PLATE FIXATION SYSTEM FOR SKULL REPAIR, THE SCREW BREAKAGE OCCURRED. THE SCREW WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW ONE WITHOUT ANY ABNORMALITIES". IT WAS ALSO REPORTED "NO ADVERSE EFFECTS ON THE PATIENT". THE EVENT WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2019 BUT HAD NOT BEEN REPORTED TO OSTEOMED, THE SCREWS INVOLVED IN THE INCIDENT WERE NOT PROVIDED FOR OUR INVESTIGATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808111 ↗