MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-27 for RELYX LUTING LUTING CEMENT 3505 manufactured by 3m Espe Dental Products.
[63304949]
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 300517-2016-00156 contains information about the first device. Based on the available information, it is not known what role, if any, the relyx luting cement played in this reported outcome. Other factors, such as prior tooth history and dental treatments, may have played a role in the need for the root canal. Moreover, the relyx luting cement was misused in this application, as it is not indicated for use with indirect composite restorations.
Patient Sequence No: 1, Text Type: N, H10
[63304950]
On (b)(6) 2016, a dental professional reported the case of a patient (age and gender not provided) who required root canal therapy on tooth #19. This tooth had received a 3m espe lava ultimate cad/cam restorative for e4d crown on (b)(6) 2014, on a tooth which had a prior restoration and decay beneath it. The crown was secured with a non-recommended cement type, 3m espe relyx luting cement. It was reported that on (b)(6) 2015, the patient required root canal therapy and replacement of the crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00157 |
| MDR Report Key | 6205082 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-27 |
| Date of Report | 2016-11-28 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-27 |
| 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 |
| 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 | 2016-12-27 |
| 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 | 2016-12-27 |