OsteoMed 214-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694026512), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.

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

• MalfunctionNov 16, 2021Fracture; Fracture

  ON 03AUG2020 THE SALES MANAGER REPORTED A PLATE FRACTURE EXPLANT IN (B)(6) WITH (B)(4). ON 05AUG2020 THE QUALITY ANALYST AT (B)(4) (OSTEOMED DISTRIBUTOR) NOTIFIES: "PATIENT (B)(6), VICTIM OF TRAUMA TO THE FACE BY A LARGE ANIMAL, UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021, WHERE TEMPORARY STABILIZATION OF THE MANDIBULAR FRACTURE AND SUTURES OF THE WOUNDS ON THE FACE WERE PERFORMED. ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT A COMPLEX MANDIBULAR FRACTURE ON THE RIGHT SIDE AND MIDDLE THIRD OF THE FACE. AT THE TIME, 01 (ONE) STRAIGHT PLATE BSSO 04 HOLES, 01 (ONE) STRAIGHT PLATE BSSO 06 HOLES AND 01 (ONE) TRAPEZOIDAL PLATE 05 HOLES OF THE 2.0 LOCKED ANGLED SYSTEM OF THE OSTEOMED BRAND WERE USED FOR FIXATION OF THE MANDIBULAR FRACTURE OF TLHE MIDDLE 1/3 OF THE FACE. IT TURNS OUT THAT, AFTER ROUTINE EXAMINATIONS, AN IMAGE COMPATIBLE WITH A 06 HOLE PLATE FRACTURE WAS FOUND IN THE BASILAR REGION OF THE MANDIBLE BODY. NEW SURGICAL INTERVENTION WAS PERFORMED TODAY (B)(6) 2021, WHERE THE TWO STRAIGHT ANGLED BSSO BOARDS BLOCKED "FRON" THE 2.0 SYSTEM WERE REMOVED AND REPLACED BY 01 (ONE) BOARD 2.4 ANGLED BLOCKED WITH 6 HOLES."

  Patient problems: Bone Fracture(s)

  MAUDE report 12819568 ↗