MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. TRIUMPH WEINGART PLIER; ORTHODONTIC PLIER

Model Number	205-202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ortho organizers, inc.Became aware on (b)(4) 2020 of an incident in (b)(4) where the tip of a triumph weingart plier broke off during use in the mouth of a patient.The patient suffered a resulting injury to the cheek and was prescribed painkillers and antibiotics for treatment.Ortho organizers received adverse event review questionnaire filled out by the dental clinic in question.On the questionnaire, the reporting doctor, dr.(b)(4), raised concern that more serious injury could have occured had the broken piece been swallowed.Manufacturer requested that the device be returned for investigation, but it has not been received.
Event or Problem Description
The tip of the triumph weingart plier broke off while being used in the mouth during orthodontic treatment resulting in injury to the inner cheek.The broken piece was retrieved without further incident.Patient was prescribed painkillers and antibiotics to treat the inner cheek injury.

• Brand Name: TRIUMPH WEINGART PLIER
• Common Device Name: ORTHODONTIC PLIER
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• MDR Report Key: 10693788
• Report Number: 2081322-2020-00002
• Device Sequence Number: 11737238
• Product Code: JEX
• UDI-Device Identifier: 00190707081621
• UDI-Public: 00190707081621
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 205-202
• Device Catalogue Number: 205-202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR