NA 449.632Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587054483), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017 OF A MANDIBULAR MODULAR LOCKING PLATE THAT BROKE IN VIVO. THE ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2017. A NON-UNION OF A BONE GRAFT MANDIBLE WAS RESECTED FROM THE SYMPHYSIS TO THE LEFT ANGLE; PLATE FAILURE OCCURRED AT THE OSTEOTOMY SITE OF THE LEFT ANGLE. REMOVED HARDWARE INCLUDED: ONE (1) BROKEN PLATE AND TEN (10) SCREWS. ALL EXPLANTED SCREWS WERE INTACT AND REMOVED EASILY. NO REPORTED SURGICAL DELAYS OR OTHER UNTOWARD EVENTS. THE PATIENT WAS REVISED TO A 2.8MM MATRIX PLATE AND SCREWS. CONCOMITANT DEVICE REPORT: 2.4MM ANTERIOR LOCKING RECON SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5), 2.4MM POSTERIOR LOCKING RECON SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5) . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7088476 ↗