MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-18 for ORTHORALIX 9200 ORTHORALIX 9200 DDE 0.822.5227 manufactured by Gendex Dental Systems.
[139088851]
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.
Patient Sequence No: 1, Text Type: N, H10
[139088852]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2019-00002 |
| MDR Report Key | 8428543 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2007-05-23 |
| Date Added to Maude | 2019-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2159975666 |
| Manufacturer G1 | DENTAL IMAGING TECHNOLOGIES CORPORATION |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHORALIX 9200 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2019-03-18 |
| Model Number | ORTHORALIX 9200 DDE |
| Catalog Number | 0.822.5227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |