MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. TRANSFORCE; ORTHODONTIC APPLIANCE

Model Number 424-532

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Ortho organizers, inc.Became aware on december 6th, 2019 of an incident in (b)(6) where an arm of a transforce appliance was broken off and swallowed by a patient whilst sleeping.X-ray confirmed that the rod was swallowed.Ortho organizers received adverse event review employee/patient questionnaire completed by markus wand (not a healthcare professional).The broken appliance will naturally pass through the patient's body.German distributor (not healthcare professional) mr.Wand assumed that reoccurrence of same malfunction could result in serious injury.However, past similar situations has resulted with patient passing the device component naturally without need for medical intervention.Subsequent follow-up with patient determined that the patient did naturally pass the device and is doing fine.Investigation of the device is not possible in this case.

Event Description

Incidence occurred in (b)(6) where an arm of a transforce appliance (orthodontic attachment) was broken off of the tooth and swallowed by the patient whilst sleeping.X-ray confirmed that the rod was swallowed and is still in the patient's body.Complaint sent to ortho organizers, inc.On december 6th 2019.

• Brand Name: TRANSFORCE
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• Manufacturer (Section G): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• Manufacturer Contact: wendy garman ; 1822 aston ave; carlsbad, ca ; 4488600
• MDR Report Key: 10693787
• MDR Text Key: 211857926
• Report Number: 2081322-2019-00002
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707060008
• UDI-Public: 00190707060008
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019,12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 424-532
• Device Catalogue Number: 424-532
• Device Lot Number: 912883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR