MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-13 for SPEEDCEM PLUS 681712WW manufactured by Ivoclar Vivadent Ag.
[105416195]
A dentist reported that after using speedcem plus to cement crowns, 5 patients experienced bite discomfort and pulpitis with pain. Of those 5 patients 2 had to undergo endodontic treatment. The relevant batch (681712ww) met all the specifications and quality criteria for release. The information provided showed two potential application errors by the dentist, which might have contributed to the postoperative sensitivities: the zirconium oxide crowns were etched before insertion, which is not indicated. The preparation of the abutment teeth was not retentive. Doctor did not return speedcem plus material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2018-00001 |
| MDR Report Key | 7429052 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-02-09 |
| Date Added to Maude | 2018-04-13 |
| 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 | MS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Manufacturer G1 | IVOCLAR VIVADENT, AG |
| Manufacturer Street | BEDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPEEDCEM PLUS |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2018-04-13 |
| Catalog Number | 681712WW |
| Lot Number | W34777 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, LS 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-13 |