MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-16 for CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570 manufactured by Dentsply Detrey Gmbh.
[70071649]
Therefore, because a serious injury resulted in this event, it is reportable per 21 cfr part 803. This report is for the third patient. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[70071650]
It was reported that four patients experienced severe pain after having a filling with ceram-x universal. The clinician removed the ceram-x fillings in all four patients and replaced them with voco composite or glass ionomer (non-dentsply products). The pain disappeared within 48 hours for each patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2017-00003 |
| MDR Report Key | 6408953 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-16 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-01-26 |
| Date Added to Maude | 2017-03-16 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457551 |
| Manufacturer G1 | DENTSPLY DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-03-16 |
| Model Number | NA |
| Catalog Number | 607.01.570 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-16 |