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

Model Number	424-532
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• MDR Report Key: 10693787
• Report Number: 2081322-2019-00002
• Device Sequence Number: 19573683
• Product Code: EJF
• UDI-Device Identifier: 00190707060008
• UDI-Public: 00190707060008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019
• Report Date (Section F): 12/06/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• 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: Other
• Patient Age: 14 YR