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U.S. Department of Health and Human Services

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

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GENDEX DENTAL SYSTEMS ORTHORALIX 9200 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
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.
 
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Brand NameORTHORALIX 9200
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDEX DENTAL SYSTEMS
1910 north penn road
hatfield PA 19440
Manufacturer (Section G)
DENTAL IMAGING TECHNOLOGIES CORPORATION
1910 north penn road
hatfield PA 19440
Manufacturer Contact
erika martin
1910 north penn road
hatfield, PA 19440
2159975666
MDR Report Key8428543
MDR Text Key139088851
Report Number2530069-2019-00002
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORTHORALIX 9200 DDE
Device Catalogue Number0.822.5227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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