OsteoMed 210-0048Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694001380), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2019Inadequacy of Device Shape and/or Size; Component Missing; Manufacturing, Packaging or Shipping Problem; Material Deformation

  THE OPERATION WAS ON (B)(6) 2019 FOR A 10MM ADVANCEMENT GENIOPLASTY. THIS SURGERY REQUIRED A SPECIFIC OSTEOSYNTHESIS PLATE - THE STRYKER GENIOPLASTY PLATE WAS MOST SUITED TO THIS TEENAGER. THE STRYKER MATERIAL ARRIVED IN THE MORNING OF (B)(6) 2019. THE SURGERY WAS SCHEDULED FOR 8AM ON (B)(6) 2019. WHEN THE SURGERY HAD BEGUN, IT WAS FOUND THAT THE STRYKER PACKAGE CONTAINED SCREWS BUT NOT PLATES. TO CONTINUE WITH THE SURGERY, AND COMPLETE THE PLANNED GENIOPLASTY, AN OSTEOMED 12MM GENIOPLASTY PLATE WAS USED (THE 10MM WAS NOT AVAILABLE) IN THE POST-OPERATIVE PERIOD THE LOWER LIP BECAME INCREASINGLY LESS COMPETENT AND THE RADIOGRAPHS SHOWED THE PLATE HAD DEFORMED UNDER THE TENSION OF THE LIMITED SOFT TISSUE. THE ANGLE HAD CHANGED FROM 80 DEGREES TO 140 DEGREES. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2019 TO CHANGE THE PLATE FROM THE OSTEOMED PLATE TO THE STRYKER PLATE.

  Patient problems: Failure of Implant

  MAUDE report 8417108 ↗