SMARTLOCK 50-20512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613154184447), received between Sep 28, 2018 and Sep 13, 2023 — classified as 1 injury, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT IT WAS FOUND THAT THE SCREWS WERE LOOSE. THE SURGEON PERFORMED A REVISION SURGERY AND ELECTED TO REMOVE A PORTION OF THE PLATE AND SCREWS BY CUTTING IT WITH A FISSURE BURR. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740758 ↗
• MalfunctionSep 28, 2018Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A 2.0 LOCKING SCREW HEAD FRACTURED OFF DURING A MANDIBLE RECONSTRUCTION CASE. THE BODY OF SCREW WAS LEFT INSIDE THE BONE. THERE WAS NO ADVERSE CONSEQUENCE NOR DELAY OF SURGERY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920225 ↗