inforMED
MalfunctionDZD

SNAPLINK

Received Nov 13, 2020

Report 2016150-2020-00005 · MDR key 10840618

Device

Generic name

Snaplink

Manufacturer

Ormco Corporation

Catalog number

438-2190, 438-2191

Product problems

  • Structural Problem

Patient

15 YR

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS ALLEGED THAT A MALFUNCTION TO SNAPLINK OCCURED, AND THE PATIENT WAS INJURED. THE PATIENT HAS RECOVERED, AND NO SERIOUS INJURY WITH THIS INCIDENT.

Description of Event or Problem

SNAPLINK GATE WOULD OPEN, AND WIRE POKED THE PATIENT IN THE CHEEK.