MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-21 for RELYX LUTING LUTING CEMENT 3505 manufactured by 3m Espe Dental Products.
[67810991]
Based on the available information, it is not known what role, if any, the relyx luting cement may have played in the reported outcome. Other factors, such as the crown margin being too close to the bone level, may have caused the pain experienced by the patient, which resulted in the crown lengthening procedure and root canal.
Patient Sequence No: 1, Text Type: N, H10
[67810992]
On (b)(6) 2016, a dentist reported that a (b)(6) female required a root canal procedure on tooth # 29. This tooth had a crown (brand unknown) seated on (b)(6) 2016 with 3m espe relyx luting cement. The dentist reported that a crown lengthening procedure was also performed in addition to the root canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00007 |
| MDR Report Key | 6345042 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-21 |
| 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 | 2017-02-21 |
| 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 | 2017-02-21 |