MAUDE Adverse Event Report: SPECIALTY APPLIANCE WORKS, INC HERBST; HERBST APPLIANCE

Catalog Number 10040T

Device Problem Solder Joint Fracture (2324)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Each device is manufactured to order according to each patients' anatomy.As such, a device is not to be used by different patients, but rather by a single patient for several months.Please note that a production account for the electronic submissions gateway (esg) was initiated on 6/7/2016.Notification was received on 7/1/2016 that the test submission failed.A new test submission was sent on 7/1/2016.The production account was approved on 7/5/2016.This report was immediately filed on 7/5/2016.Notification was received on 7/7/2016 that the submission failed.A new submission was sent on 7/7/2016.

Event Description

On (b)(6) 2016, patient's parent noticed that a wire (.032" diameter and approximately 21 mm in length) from the expander was missing.The patient was not aware that the wire came off and in advertently swallowed the wire.Patient went to emergency room to seek medical attention.On (b)(6), patient received a follow-up x ray.On (b)(6), patient was advised that the wire had passed and was released.Subsequently on (b)(6), patient felt a sharp wire in her mouth.An occlusal rest came off and the patient swallowed the wire.Patient sought treatment at the emergency room.X rays were taken to locate the wire.The wire was found in the small intestine.Patient was advised that wire would pass and to come back if she experienced cramping, bleeding or pain.The herbst appliance was seated on (b)(6) 2016 and was removed on (b)(6) 2016.

• Brand Name: HERBST
• Type of Device: HERBST APPLIANCE
• Manufacturer (Section D): SPECIALTY APPLIANCE WORKS, INC; 4905 hammond industrial drive; cumming GA 30041
• Manufacturer (Section G): SPECIALTY APPLIANCE WORKS, INC; 4905 hammond industrial drive; cumming GA 30041
• Manufacturer Contact: carolyn thomas ; 4905 hammond industrial drive; cumming, GA 30041 ; 6785134408
• MDR Report Key: 5776149
• MDR Text Key: 49029113
• Report Number: 3004158247-2016-00001
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 10040T
• Device Lot Number: 6469124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR