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.
[71682652]
Based on the available information, it is not known what role, if any, lava ultimate played in the reported patient outcome. Other factors, such as prior tooth history or other dental treatments, may have played a role in the need for tooth extraction.
Patient Sequence No: 1, Text Type: N, H10
[71682653]
This case was identified through post-market surveillance activities. Records provided by the dental professional indicated that this female patient (age or date-of-birth were not provided) required extraction of tooth #19. This tooth had received a lava ultimate crown on (b)(6) 2013, because the prior restoration on the tooth had open margins. In addition, this tooth had undergone root canal treatment at some prior point. On (b)(6) 2013, the lava ultimate crown was adjusted because of sensitivity. On (b)(6) 2015, the patient reported a dull ache in the area around this tooth; notes indicate that the dentist believed this was due to soft tissue issues because of the pre-existing root canal. On (b)(6) 2016, the crown was noted as loose; it was removed, decay was identified and the tooth was extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00035 |
| MDR Report Key | 6458691 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-14 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2017-03-14 |
| 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 |