MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-27 for OBSIDIAN PRESS ASKU manufactured by Prismatik Dentalcraft, Inc..
[115393544]
The reported product was discarded by the customer. Once the evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[115393545]
It was reported that fracture was observed on an obsidian screw retained crown. The lot number of the ingot is unknown and the crown was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2018-00258 |
| MDR Report Key | 7728874 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-27 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-07-27 |
| 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. TOAN HOANG |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9492251235 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBSIDIAN PRESS |
| Generic Name | OBISIDIAN PRESS |
| Product Code | EIH |
| Date Received | 2018-07-27 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |