MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GENDEX EXPERT DC; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 1.005.4516

Device Problem Installation-Related Problem (2965)

Patient Problem Laceration(s) (1946)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

The device was reinstalled and will not be returned to the manufacturer for further evaluation.Photos provided from the office revealed visual evidence that the wall backing material was not sufficient to support the full weight of the unit resulting in the mounting hardware pulling out of the wall.The expert dc installation manual (032-0204-en) provides instructions for proper device mounting based on the installer's assessment of the condition of the wall.The malfunction was determined to be the result of an improper installation.This concludes our investigation.

Event Description

The device became dislodged and fell off the wall during a scan and made contact with the patient.The patient sustained a laceration to the head and was being observed for concussion symptoms.No serious injury has been reported.

• Brand Name: GENDEX EXPERT DC
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 5762931
• MDR Text Key: 48620392
• Report Number: 2530069-2016-00009
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K992610
• 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: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 1.005.4516
• Device Catalogue Number: EXPERTDC65 WW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 44 YR