MAUDE Adverse Event Report: DENTAL IMAGING TECHNOLOGIES CORPORATION GENDEX GX-770; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number GX-770

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned to the manufacturer for evaluation.A cause as to the malfunction of the unit component cannot be determined.The actual date of manufacture cannot be determined; however, the gx-770 was discontinued from sale on 03/31/2010 and manufacturer support of the device ended on 03/31/2017.This concludes the investigation.

Event Description

It was reported the horizontal arm broke loose where it meets the control panel.There was no report of patient or user involvement.No injuries were reported.

Manufacturer Narrative

Patient indentifier has been corrected to include the correct patient identifier.

• Brand Name: GENDEX GX-770
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): DENTAL IMAGING TECHNOLOGIES CORPORATION; 1910 north penn road; hatfield PA 19440
• MDR Report Key: 8369709
• MDR Text Key: 137561089
• Report Number: 2530069-2019-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K935046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1