MAUDE Adverse Event Report: ARIBEX NOMAD DENTAL; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Breast Mass (2439)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

The unit has been returned and will be evaluated by a third party.Specific patient information is not yet available.A follow-up report will be submitted upon evaluation completion.

Event Description

It was reported by the office manager that a doctor found a lump in the breast of a dental hygienist in the office and they believe that the nomad dental x-ray system is a contributing factor.The dental office asked to have the unit evaluated for extra exposure.

Manufacturer Narrative

The unit was returned to aribex and an internal investigation was conducted, as well as, an evaluation by an independent physics service.The unit was found to be within all specifications and no damage was found to the unit.Based on measurements made on the unit, the maximum exposure rate to an operator of the device is significantly below the applicable dose limits to both body and hands of the operator of the unit.The evaluation concluded that the unit is operating as expected and within established performance specifications.Aribex is unable to confirm the complaint.This concludes the investigation.

• Brand Name: NOMAD DENTAL
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: erika martin ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877241
• MDR Report Key: 6640303
• MDR Text Key: 77542942
• Report Number: 1017522-2017-00036
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: 0.850.0000
• Device Catalogue Number: 0.850.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening