MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for X-SMART PLUS CONTRA ANGLE A103200000000 manufactured by Dentsply Maillefer.
[184877322]
There has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona. Received - 1x x-smart plus cartridge h1033c1051015. 1x x-smart plus drive shaft h1033c1051022. X-smart plus cartridge bad maintenance (user) there is some rust on the cartridge. X-smart plus drive shaft various mechanical problem rotation not fluid.
Patient Sequence No: 1, Text Type: N, H10
[184877323]
In this event it was reported that a x-smart plus contra angle won't hold drills. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2019-00317 |
| MDR Report Key | 9878662 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2019-12-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | NAKANISHI INC. |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-SMART PLUS CONTRA ANGLE |
| Generic Name | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL |
| Product Code | EGS |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-19 |
| Model Number | NA |
| Catalog Number | A103200000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |