MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-04 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.
[71683564]
This manufacture report is for the first of two individual patient cases identified in manufacturing report 3005174370-2016-00041 follow-up 1. Based on the available information, it is not known what role, if any, the lava ultimate restorative material played in this reported outcome. Other factors, such as prior tooth history and dental treatments, may have played a role in the need for root canal treatment.
Patient Sequence No: 1, Text Type: N, H10
[71683565]
On (b)(6) 2017, a dental professional reported the case of a female patient ((b)(6)) who required root canal treatment on tooth #4. This tooth had a lava ultimate crown placed on (b)(6) 2013, because the pre-existing restoration had decay beneath it. On (b)(6) 2017, it was reported that the crown had fractured and secondary caries were discovered. Subsequently, root canal treatment was performed, core build up was done and a non-3m crown placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00033 |
| MDR Report Key | 6458670 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-04-04 |
| 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 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2052-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-04-04 |
| Catalog Number | 2914A2-LT |
| 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 | 2017-04-04 |