OsteoMed 338-2712Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694042567), received between Aug 5, 2021 and Aug 5, 2021 — classified as 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. 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.

• MalfunctionAug 5, 2021Break; Break

  ON (B)(6) 2021 OSTEOMED WAS NOTIFIED THAT, DURING A FOLLOW UP VISIT DUE TO DISCOMFORT ON THE THE LEFT FOOT OF THE PATIENT; THE X-RAY'S FROM (B)(6) 2021 REFLECTS THAT THE PLATE IMPLANTED ON (B)(6) 2020 WAS BROKEN. PER THE REPORTER: "THE PATIENT PRESENTED DISCOMFORT AND AT THE TIME OF THE REVIEW IT WAS DETECTED THAT THE PLATE (336-2710) HAD FRACTURED, THE DOCTOR INDICATES THAT HE HAS NO SIGNS THAT THE PATIENT HAS EXPOSED THE PLATE TO FATIGUE." THE INVOLVED PART NUMBERS ARE AS FOLLOWS: PART NUMBER DESCRIPTION LOT # QUANTITY 336-2710 2.7 MM 10 HOLE SUBCONDYLAR PLATE 1139811 1. 338-2710 2.7 X 10MM FULLY THREADED ANGLED LOCKING 1129481 2. 338-2712 2.7 X 12MM FULLY THREADED ANGLED LOCKING 1129482 1. 338-2716 2.7 X 16MM FULLY THREADED ANGLED LOCKING 1128465 1. 338-2718 2.7 X 18MM FULLY THREADED ANGLED LOCKING 1136613 1.

  Patient problems: Discomfort

  MAUDE report 12285265 ↗