MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-26 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D N/A 3114A2-LT manufactured by 3m Espe Dental Products.
[131470555]
Patient specific information was not provided. Product lot and serial # information was not provided. Product lot # information was not provided. Manufacture date is unknown. The dental office indicated patient-specific information would be provided to 3m to assist in the investigation; however, to date, this information has not been made available. No product samples were returned for evaluation; thus, engineering evaluation of the actual product is limited. Based on the limited information provided to 3m on this case, it is unclear what role, if any, the lava ultimate restoration may have played in the reported outcome. Other factors, such as prior tooth history, patient factors or dental treatments, may have played a role in the reported need for tooth extraction.
Patient Sequence No: 1, Text Type: N, H10
[131470556]
On (b)(6) 2018, a dentist reported to 3m that some of his patients who had lava ultimate crowns placed between 2012 through 2015 required tooth extraction because of decay beneath the crown. The dentist did not provide a specific number of cases that have occurred, the dates on which the extractions took place or other information to assist in the investigation of this report (such as the type of cement used to seat the crown). The dentist states he believes he followed correct placement protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2018-00008 |
| MDR Report Key | 8197997 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-12-26 |
| 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 | MS. SUZANNE LEUNG |
| Manufacturer Street | 2510 CONWAY AVENUE BUILDING 275-02-W-08 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6515758052 |
| 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 E4D |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2018-12-26 |
| Model Number | N/A |
| Catalog Number | 3114A2-LT |
| Lot Number | N/A30605861041233 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-26 |