MAUDE Adverse Event Report: ORMCO CORPORATION NI-TI WIRE; WIRE, ORTHODONTIC

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

A doctor alleged that the niti archwire had broken in a patient's mouth and the patient had swallowed the broken part during daily activity.

Manufacturer Narrative

Specific patient information with regard to gender, age and weight was not provided.Although the doctor identified two (2) different catalog numbers associated with the breakage of the wire, he could not verify which catalog number had broken; therefore, no lot numbers were identified.The catalog numbers involved in the alleged incident included catalog numbers 205-0004, 205-0008.The patient sought further medical attention at the emergency room.An x-ray was taken and surgery was performed to remove the broken part.It was reported that the doctor believes that the archwire had been broken through deliberate and careless action by the patient.No further patient health status information was reported.An update will be provided if any further information is obtained.The product involved in this incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted.

• Brand Name: NI-TI WIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 s. lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 4853075
• MDR Text Key: 21120369
• Report Number: 2016150-2015-00017
• Device Sequence Number: 1
• Product Code: ECN
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention