MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS ORTHORALIX 9200; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number ORTHORALIX 9200 DDE

Device Problems Unintended System Motion (1430); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation was conducted via telephone with the dental office to obtain further information related to the report that the device column motor failed, causing the overhead to drift down and touch the patient's head.The office stated a dental hygienist was positioning the patient for a pan scan using the orthoralix 9200 dde when the column motor failed and the overhead pan drifted down and was leaning on the patient's head.The patient was an (b)(6) female of average height (b)(6).The hygienist raised the overhead with her arm and removed the patient from the device.When overhead was released, it drifted down the column towards the floor.There was no injury to the patient or staff.There was no first aid administered to the patient.In addition, the office had followed up to make sure the patient was okay the following day.At this time, the office has not determined if the unit will be repaired or replaced.This concludes the investigation.

Event Description

It was reported by a technician the column motor failed and slightly fell on a patient.It was also reported that the office staff was able to catch the overhead and hold it before the weight of it fell on the patient.The cables are intact.The buttons on the panel still work.The unit grinds when trying to move up or down.There was no report of injuries and no report of medical attention.

Manufacturer Narrative

The assembly, motor reducer, column was returned to the manufacturer for investigation.The main drive motor was examined and a physical inspection of the gear train revealed that the main drive pully had become loose and was spinning on the output drive shaft.It was observed that the set screw had backed off from the registration dimple on the output drive shaft.Based on the visual evaluation, the main drive motor was unable to hold the overhead in the upward position against the weight of the upper assembly as a result of the set screw backing off from the registration dimple on the output drive shaft.The root cause for the set screw backing off is inconclusive.This concludes the investigation.

• Brand Name: ORTHORALIX 9200
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• MDR Report Key: 8428543
• MDR Text Key: 139088851
• Report Number: 2530069-2019-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K032355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORTHORALIX 9200 DDE
• Device Catalogue Number: 0.822.5227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR