SMARTLOCK 55-10556Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540366252), received between Jun 13, 2018 and Mar 5, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Fracture

  IT WAS REPORTED THAT A PLATE FRACTURE WAS IDENTIFIED, AND REVISION SURGERY IS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523623 ↗
• InjuryFeb 19, 2026Fracture

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OF THE MANDIBULAR LOCKING SAGITTAL PLATE OCCURRED, REQUIRING REMOVAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388501 ↗
• MalfunctionNov 14, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554101 ↗
• MalfunctionSep 12, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037075 ↗
• InjuryNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED PLATE BROKE POST OP AND A REVISION SURGERY TO REMOVE AND REPLACE THE PLATE WILL TAKE PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873258 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT IT WAS NOTICED 1 YEAR POST OPERATIVE, THAT THE PLATE IMPLANTED WAS BROKEN. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689581 ↗
• MalfunctionFeb 16, 2021Fracture; Fracture

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT IT WAS NOTICED 1 YEAR POST OPERATIVE, THAT THE PLATE IMPLANTED WAS BROKEN. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335432 ↗
• MalfunctionFeb 16, 2021Fracture; Fracture

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT IT WAS NOTICED 1 YEAR POST OPERATIVE, THAT THE PLATE IMPLANTED WAS BROKEN. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335428 ↗
• MalfunctionFeb 16, 2021Fracture; Fracture

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT IT WAS NOTICED 1 YEAR POST OPERATIVE, THAT THE PLATE IMPLANTED WAS BROKEN. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335427 ↗
• MalfunctionMar 20, 2019Break; Fracture; Fracture

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING A POST-OPERATIVE CT, AN IMPLANT PLATE SCREW HOLE WAS FOUND TO BE DAMAGED. NO INFORMATION WAS PROVIDED ON HOW THE PLATE SCREW HOLE WAS DAMAGED. THERE WAS NO ADVERSE EVENT TO THE PATIENT AND NO REVISION SURGERY WILL BE PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436285 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. DUE THE INFECTION THE SURGEON HAD TO EXPLANT THE PLATE AND SCREWS.

  Patient problems: Unspecified Infection

  MAUDE report 7647866 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. POTENTIALLY, DUE THE INFECTION THE SURGEON MAY HAVE TO EXPLANT THE PLATE AND SCREWS.

  Patient problems: Unspecified Infection

  MAUDE report 7647865 ↗
• InjuryJun 28, 2018Appropriate Device Problem Term/Code Not Available

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. DUE THE INFECTION THE SURGEON HAD TO EXPLANT THE PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 7647794 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. DUE THE INFECTION THE SURGEON HAD TO EXPLANT THE PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 7647784 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. DUE THE INFECTION, THE SURGEON HAD TO EXPLANT THE PLATES.

  Patient problems: Unspecified Infection

  MAUDE report 7607147 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. DUE TO THE INFECTION, THE SURGEON HAD TO EXPLANT THE PLATES.

  Patient problems: Unspecified Infection

  MAUDE report 7597914 ↗