MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-15 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.
[100202379]
Based on the limited information provided to 3m on this case, it is not clear what role, if any, the use of lava ultimate may have had in the reported outcome. Other patient factors, such as prior tooth history, patient factors and dental treatments, may have played a role in the need for the root canal therapy.
Patient Sequence No: 1, Text Type: N, H10
[100202380]
On (b)(6) 2018, a dental office reported that five patients (ages and genders not provided) with a lava ultimate restoration required root canal treatment due to the discovery of recurrent decay. Further patient specific information on the date of seating, date of failure, and tooth history was not provided to 3m.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2018-00001 |
| MDR Report Key | 7274214 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2018-02-15 |
| 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 | 2018-02-15 |
| 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 | 2018-02-15 |