MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-04 for RELYX LUTING LUTING CEMENT 3505 manufactured by 3m Espe Dental Products.
[63910988]
Since there were two medical devices involved in this event, two manufacturer reports are being submitted. This report contains information about the second device. Manufacturer report 300517-2017-00001 contains information about the first device. Based on available information, it is not known what role, if any, the lava ultimate crown or the relyx luting cement may have played in this reported patient outcome. Other factors, such as prior tooth history or dental treatment, may have played a role in the need for root canal therapy. 3m espe relyx luting cement has a highly favorable clinical usage history and in the last 8 years, 3m has not received any other reports of root canals in patients whose restorations were secured with this product.
Patient Sequence No: 1, Text Type: N, H10
[63910989]
On (b)(6) 2016, a dental professional reported the case of a patient (age and gender not provided to 3m) who required root canal therapy on tooth #31. This tooth had a lava ultimate cad/cam restorative for e4d crown placed on (b)(6) 2013, because a prior restoration in that tooth had caries beneath it. The crown was seated with 3m espe relyx luting cement, a product which is not intended to be used with lava ultimate. On (b)(6) 2016, the patient received root canal treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00002 |
| MDR Report Key | 6224221 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-04 |
| Date of Report | 2016-11-24 |
| Date of Event | 2016-01-18 |
| Date Mfgr Received | 2016-11-24 |
| Date Added to Maude | 2017-01-04 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX LUTING LUTING CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2017-01-04 |
| Catalog Number | 3505 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-04 |