MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-08-10 for 3M ESPE RELYX LUTING PLUS CEMENT 3525TK manufactured by 3m Espe Dental Products.
[82458035]
Upon 3m follow-up with the patient's pediatric dentist who placed the stainless steel crown, a perforation of a stainless steel crown is not unusual, especially after almost three years, and could be caused by the masticatory function of the child or bruxism. However, it should be noted that 3m has not received any similar complaints of this nature in the past. This event involved two 3m products; therefore, two manufacturer reports are being submitted. This report represents the second product. Manufacturer report 3005174370-2017-00044 represents the second product.
Patient Sequence No: 1, Text Type: N, H10
[82458036]
On (b)(6) 2017, 3m was notified that an (b)(6) year-old male patient required a tooth extraction due to tooth decay which was noted after a 3m stainless steel crown fell off his tooth. The stainless steel crown was reported to have a hole in the center surface. The crown was originally placed in (b)(6)2014 using 3m espe relyx luting plus cement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00045 |
| MDR Report Key | 6786846 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-08-10 |
| 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 |
| 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 |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE RELYX LUTING PLUS CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2017-08-10 |
| Catalog Number | 3525TK |
| 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 | 2017-08-10 |